Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Expected Areas of Competence:

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Expected Areas of Competence:

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

In the role of the Finance Director Hungary you will be leading the core finance function on the market, supervising accounts, business control, financial planning and analysis processes and serve as a trusted business partner to Hungary General Manager and the local team.

In this role you will:

• Develop and implement financial strategies to support the company's objectives
• Support and partner with Hungary General Manager on delivering business results and goals
• Have financial responsibility for 2 legal entities one BMS & one Celgene (will evolve to 1 LE)
• Lead the Hungary Finance team, build and develop a diverse, high performing team by attracting and retaining the best talent, establishing and communicating high standards, establishing and implementing development plans, serving as role model in providing feedback and coaching
• Effectively partner with the regional GFS team that provides the financial transactional, tax and treasury support, and with Procurement and Information Management groups driving continuous improvement
• Be a member of the Hungary Operating Committee where act as a trusted business partner, providing direction and expertise to BMS Hungary for finance and operational functions and assisting the Hungary Operating Committee in decision making and meeting financial commitments
• Be a member of the CEETII Finance Team, contributing to regular team meetings
• Oversee Financial Analysis processes and tasks, i.e. Budget, Projection, monthly sales and expense analysis. Establish appropriate budget goals aligned with external market place and strategy
• Monitor business performance, challenge results and develop recommendations to improve financial performance in close collaborating with local commercial teams
• Present budgets, financial results, variances and other financial data to peers and senior management in an articulate and succinct manner
• Create a strong Internal Control environment: Ensure compliance with BMS internal control standards, Sarbanes-Oxley and FCPA, exhibit exemplary standards of integrity
• Be a Finance representative of the market and represent the Hungary entities legally as Proxy. Act as statutory director for the legal entities of BMS in Hungary
• Manage and control operating entity ink sign-off on transactions/contracts and coordinate all important tax, legal and treasury matters with local Country Controller, legal counsel and Headquarters
• Act as proxy of the General Manager in case of her / his absence
• Develop and communicate a compelling vision for the financial functions that is aligned with the overall business strategy and communicate it clearly and with passion to all relevant stakeholders
• Foster an organizational culture of customer focus, innovation, winning attitude and competitiveness
• Know the local economic, market and industry trends and use appropriate information to maximize opportunities and minimize risk exposure
• Anticipate business trends assess risk and recommend alternative solutions and contingency plans to ensure meeting financial and business objectives. Propose innovative solutions to business situations and finance processes.
• Demonstrate good balance between controls & competitiveness without any compromise in compliance.
• Develop in-market business relationship network with external entities such as other Pharma Industry FDs associations, authorities, banks, consultants, etc.
• Build and maintain strong relationship with internal stakeholders, other functions in the organization, marketing and sales teams and international support staff, so as to capitalize on opportunities to enhance performance
• Build personal credibility and strong working relationships, break barriers and influences across organizational and / or geographical boundaries leading to efficiency, effectiveness and agility for optimized organizational performance, both in own markets and across region

Expected areas of competences:

• University degree/ Masters degree in Finance or Business Administration; additional Accountancy qualifications preferred
• Sound financial background & at least 3-5 years management experience in financial position. Previous people management experience is desirable
• Strategic thinking, analytical mindset and ability to manage competing priorities in a highly complex environment
• Good knowledge of the pharmaceutical industry and the companies within it
• Good understanding of the healthcare system and the different customer groups within it
• Experience in working cross-functionally at management level and ability to facilitate business decision-making
• Good communication skills both verbally and in writing along with the good listening skills
• Ability to make and implement sound and well thought-out decisions
• High level of energy, able to influence and generate strong commitment
• Good team player with strong business partnering skills and very pragmatic way of acting
• Good balance of operational and strategic focus
• Fluency in English, Hungarian is a plus
• Candidate who aspires an international career and is therefore mobility will be an asset.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

1. Assign resource for each clinical trial according to study needs.

2. Identify SMN's capability gap timely and provide on-job coaching to ensure study quality.

3. Review SMN's performance and identify team training needs and provide training.

4. Support study team to meet study KPI and alignment.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol Myers Squibb is a global biopharmaceutical company committed to transforming patients’ lives through science.  At the core of that mission are the talented individuals who contribute their “unique” skillsets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we’re looking for talented professionals like you to join our team. What unique gene will you bring?

Business partner accountable for supporting the strategic plans and ensuring value realization of digital capabilities used by Corporate & Gov’t Affairs. This role also contributes and supports the digital strategy of the company and collaborates with IT build-and-run leaders to identify strategic and innovative uses of technology, leveraging enterprise platforms and cloud solutions to drive business growth and profitability.​

Key responsibilities:

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. We are focused on helping millions of patients around the world in disease areas such as oncology, hematology, immunology, cardiovascular and fibrosis.

Summary/Scope

Reporting to the Executive Director, Translational Early Development, the Translational Early Program Lead will be part of the Immunology, Cardiovascular, Fibrosis, and Global Health (ICFG) Thematic Research Center (TRC) based in Cambridge, MA or Princeton or Summit, NJ. Working in a cross functional team, the individual will be responsible for the development of the clinical biomarker strategy for early stage drug development programs in immunology and fibrotic diseases. This individual will also have matrixed responsibilities to guide research programs within the translational research laboratories, and will act as the translational development ICFG TRC representative in early development teams and assume primary responsibilities, such as interacting with CROs and KOLs to support contracting, sample analysis, and data delivery and interpretation of biomarkers in clinical studies.  The successful candidate will have prior experience interacting with project teams, clinical research physicians, statisticians, computational biologists, contract research organizations and translational scientists to deliver science that accelerates the development of medicines for patients in need.   

Responsibilities will include, but are not limited to, the following:

• Responsible for managing the timelines and activities associated with clinical biomarker data delivery such as biomarker and assay selection, contracting (with support from an operations group), sample analysis, interpretation, and report generation, as well as involvement in trial-specific biomarker deliverables (e.g. biomarker plan, protocol development, study reports)
• Work with internal translational research groups or CROs to develop and validate and selected biomarker assays for clinical implementation
• Implements innovative translational activities in early clinical studies through direct interaction with clinical research physicians, statisticians, clinical operations, computational biologists, contract research organizations, academic experts, and internal translational scientists
• Acts as a liaison between scientific and clinical project representatives to bridge the gap between discovery/translational research and clinical early development and enable back-translation from clinical studies to bench scientists
• Aid in biomarker data delivery for clinical studies through working with relevant functions and CROs; supports development of SOWs and interfacing with CRO for execution of services
• Participates in evaluation of CROs for data analysis and delivery capabilities, as needed
• Identify and collaborate in disease or therapeutic area-specific academic/industry partnerships and consortia, with the goal of advancing scientific understanding of disease pathophysiology to enable early target and biomarker identification and validation
• Prepares and delivers internal and external presentations
• Supports regulatory submissions and regulatory interactions as needed

Skills/Knowledge Required

• Experience in the relevant disease areas
• Understanding of drug discovery and development, especially transition from preclinical to clinical stage of development
• Experience in activities required for and related to clinical trial initiation, maintenance, and completion
• Experience in global regulatory interactions
• Experience in interacting with CROs and KOLs to manage projects and timelines
• Proven scientific/leadership expertise (working in teams, mentoring people, managing projects)
• Experience in mining of large datasets, either independently or in collaboration with bioinformaticians to understand disease pathophysiology and/or establish patient segmentation hypotheses
• Excellent record of performance and scientific accomplishments as demonstrated by impactful contributions to the scientific community, pipeline contributions, peer reviewed publications and patent applications highly desired
• Accountable for timelines and deliverables
• Prioritizes risks and implements contingency plans
• Communicates regularly; prepares and delivers presentations within the department, to governance and senior leadership bodies, and externally
• Recognizes cross-functional issues and communicates within the larger organization. Provides expert guidance to multi-disciplinary teams and senior management. Has a track record of delivering results, driving continuous improvements, and building effective cross-functional networks.
• Ability to prioritize and manage time efficiently
• Strong verbal and written communication skills
• Accurate and detailed record keeping
• Excellent organizational skills
• Ability to collaborate in teams and work with others in a matrixed environment

Education:

Ph.D. and 10+ years of biotechnology / pharmaceutical industry and/or relevant experience. Candidate must be a rigorous, detail-oriented scientist, with excellent record keeping and organizational skills. Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced dynamic environment.

Functional/Scientific/Technical Skills:

• Contributing to research program and business.

• Subject matter leader.

• Broad knowledge of multiple functional technologies.

• In-depth understanding of function as it relates to project.

• Functional area expert with skills, theoretical knowledge and experience to apply scientific direction and approach to projects and problems.

Tasks and Responsibilities:

• Completes technical assignments by designing, executing and interpreting complex experiments.

• Recommends department level strategic decisions.

• May lead scientifically on cross functional assignments.

• Manages and/or coordinates workflow on projects.

• Apply diverse scientific knowledge to assignments.

• Development of research tools.

• Interpret results.

Discretion/Latitude:

• Helps design operational strategies consistent with department goals.

• Provides input and makes recommendations to research strategies.

Creativity and Problem Solving:

• Identify & solve multi-faceted challenges.

• Recognizes problems and is able to recommend and develop appropriate solutions from prior experience, literature, or collaboration.

• Identify risks.

• Contributes ideas and develops/presents a scientific case (or position) inside and outside department/group.

Teamwork and Influence:

• Communicates with cross functional team.

• Directly impacts the achievement of workgroup/team goals.

• Represents workgroup/team or department on multi-disciplinary or cross functional teams.

• Work across departments.

Organizational Impact:

• Direct impact on departmental performance.

• Impact is achieved by driving team efforts.

• Able to conceptualize broad impact of research programs and personal activities

Behavioral Competencies:

• Champions change

• Leads courageously

• Networking

• Provides directions

• Structuring and staffing
• Thinks strategically

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. We are focused on helping millions of patients around the world in disease areas such as oncology, hematology, immunology, cardiovascular and fibrosis.

Summary/Scope

Reporting to the Executive Director, Translational Early Development, the Translational Early Program Lead will be part of the Immunology, Cardiovascular, Fibrosis, and Global Health (ICFG) Thematic Research Center (TRC) based in Princeton or Summit, NJ. Working in a cross functional team, the individual will be responsible for the development of the clinical biomarker strategy for early stage drug development programs in cardiovascular and fibrotic diseases. This individual will also have matrixed responsibilities to guide research programs within the translational research laboratories, and will act as the translational development ICFG TRC representative in early development teams and assume primary responsibilities, such as interacting with CROs and KOLs to support contracting, sample analysis, and data delivery and interpretation of biomarkers in clinical studies.  The successful candidate will have prior experience interacting with project teams, clinical research physicians, statisticians, computational biologists, contract research organizations and translational scientists to deliver science that accelerates the development of medicines for patients in need.   

Responsibilities will include, but are not limited to, the following:

• Responsible for managing the timelines and activities associated with clinical biomarker data delivery such as biomarker and assay selection, contracting (with support from an operations group), sample analysis, interpretation, and report generation, as well as involvement in trial-specific biomarker deliverables (e.g. biomarker plan, protocol development, study reports)
• Work with internal translational research groups or CROs to develop and validate and selected biomarker assays for clinical implementation
• Implements innovative translational activities in early clinical studies through direct interaction with clinical research physicians, statisticians, clinical operations, computational biologists, contract research organizations, academic experts, and internal translational scientists
• Acts as a liaison between scientific and clinical project representatives to bridge the gap between discovery/translational research and clinical early development and enable back-translation from clinical studies to bench scientists
• Aid in biomarker data delivery for clinical studies through working with relevant functions and CROs; supports development of SOWs and interfacing with CRO for execution of services
• Participates in evaluation of CROs for data analysis and delivery capabilities, as needed
• Identify and collaborate in disease or therapeutic area-specific academic/industry partnerships and consortia, with the goal of advancing scientific understanding of disease pathophysiology to enable early target and biomarker identification and validation
• Prepares and delivers internal and external presentations
• Supports regulatory submissions and regulatory interactions as needed

Skills/Knowledge Required

• Experience in the relevant disease areas
• Understanding of drug discovery and development, especially transition from preclinical to clinical stage of development
• Experience in activities required for and related to clinical trial initiation, maintenance, and completion
• Experience in global regulatory interactions
• Experience in interacting with CROs and KOLs to manage projects and timelines
• Proven scientific/leadership expertise (working in teams, mentoring people, managing projects)
• Experience in mining of large datasets, either independently or in collaboration with bioinformaticians to understand disease pathophysiology and/or establish patient segmentation hypotheses
• Excellent record of performance and scientific accomplishments as demonstrated by impactful contributions to the scientific community, pipeline contributions, peer reviewed publications and patent applications highly desired
• Accountable for timelines and deliverables
• Prioritizes risks and implements contingency plans
• Communicates regularly; prepares and delivers presentations within the department, to governance and senior leadership bodies, and externally
• Recognizes cross-functional issues and communicates within the larger organization. Provides expert guidance to multi-disciplinary teams and senior management. Has a track record of delivering results, driving continuous improvements, and building effective cross-functional networks.
• Ability to prioritize and manage time efficiently
• Strong verbal and written communication skills
• Accurate and detailed record keeping
• Excellent organizational skills
• Ability to collaborate in teams and work with others in a matrixed environment

Education:

Ph.D. and 10+ years of biotechnology / pharmaceutical industry and/or relevant experience.  Candidate must be a rigorous, detail-oriented scientist, with excellent record keeping and organizational skills. Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced dynamic environment.

Functional/Scientific/Technical Skills:

• Contributing to research program and business.

• Subject matter leader.

• Broad knowledge of multiple functional technologies.

• In-depth understanding of function as it relates to project.

• Functional area expert with skills, theoretical knowledge and experience to apply scientific direction and approach to projects and problems.

Tasks and Responsibilities:

• Completes technical assignments by designing, executing and interpreting complex experiments.

• Recommends department level strategic decisions.

• May lead scientifically on cross functional assignments.

• Manages and/or coordinates workflow on projects.

• Apply diverse scientific knowledge to assignments.

• Development of research tools.

• Interpret results.

Discretion/Latitude:

• Helps design operational strategies consistent with department goals.

• Provides input and makes recommendations to research strategies.

Creativity and Problem Solving:

• Identify & solve multi-faceted challenges.

• Recognizes problems and is able to recommend and develop appropriate solutions from prior experience, literature, or collaboration.

• Identify risks.

• Contributes ideas and develops/presents a scientific case (or position) inside and outside department/group.

Teamwork and Influence:

• Communicates with cross functional team.

• Directly impacts the achievement of workgroup/team goals.

• Represents workgroup/team or department on multi-disciplinary or cross functional teams.

• Work across departments.

Organizational Impact:

• Direct impact on departmental performance.

• Impact is achieved by driving team efforts.

• Able to conceptualize broad impact of research programs and personal activities

Behavioral Competencies:

• Champions change

• Leads courageously

• Networking

• Provides directions

• Structuring and staffing
• Thinks strategically

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

This Executive Associate position reports to the Executive Director Worldwide Health Economics & Outcomes Research (WW HEOR) Oncology, and supports the Executive Director WWHEOR Heme and teams and requires excellent executive associate experience. The Executive Associate performs highly diverse administrative and project focused duties, which by nature of the position may involve high level contacts and exposure to confidential material necessitating the use of tact, diplomacy, discretion and judgment.  We are looking for a dynamic, performance driven, well-organized and flexible individual who thrives in a fast-paced environment.  The candidate must have proven skills in prioritizing and multi-tasking, as well as the ability to remain poised and focused in a fast-paced working environment.

Responsibilities (include, but are not limited to):

• Conserves executive's/leader’s time by reading, spell & grammar checking, researching, and routing correspondence; drafting letters and documents; collecting and analyzing information; initiating telecommunications.
• Phone and calendar management as well as timely scheduling ensuring meetings are prioritized and occur within appropriate timelines.
• Maintain and organize office operations and procedures such as filing system, expense reports as appropriate, purchase orders, office supply orders, and other administration services.
• Prioritizes activities and takes prompt action based on an understanding of departmental objectives and business needs.
• Adhere to T&E policies, including booking international and domestic travel and monthly reconciliation of business expenses for executive(s).
• Ensure manager’s preparedness for all meetings (e.g., assemble meeting materials, technology testing, communication to attendees & pre-reads).
• Prioritize and complete support requests in a timely manner (i.e. issues with IT, systems, facilities, etc.)
• Independently researches more complex inquiries and responds or escalates inquiry, recommending solutions as appropriate.
• Maintains professional and technical knowledge by remaining current with BMS continuous learning modules.
• Creates and manages purchase order and related processes.
• Meeting planning and logistics support.
• Supports teams and assists in VP office as necessary.

Qualifications:

• High School degree, some college or degree desirable.
• 8 years administrative or comparable experience; prior BMS and Executive Associate Experience preferred.
• Experience in working with international teams is desirable.
• Must possess the ability to take initiative and adapt to frequently changing priorities.
• Ability to work and think independently with the ability to analyze and solve complex problems with excellent judgment and provide high quality work with attention to detail.
• Proactive, solution-oriented approach to collaboration with strong decision-making capability in order to guide assigned projects to successful conclusions.
• Proficient with Microsoft Suite (Outlook, Word, Excel, Power Point). Knowledge of BMS Systems and Processes strongly preferred.
• Concur Travel and T&E, Ariba/SAP, Sharepoint, eSetup, Workday, Room Scheduler experience strongly desired.
• Demonstrates ability to prioritize, pro-actively work independently and collaboratively with other administrative assistants/external partners, across organizational levels, functions, and supports business needs across different time-zones and during periods of heavy workload.
• Ability to multi-task and adapt quickly to competing priorities while remaining focused.
• Successful candidate must be able to learn new tools and systems in an ever-evolving environment.
• Exhibits a positive work attitude and high productivity.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

MAJOR DUTIES AND RESPONSIBILITIES

State the most important activities and accountabilities of this position.

 These activities and accountabilities can influence the achievement of company or business goals.  (Attach additional sheets if needed):

Serves as key member of the Site Quality Leadership team translating quality requirements, improvement and change initiatives into operating plans for the Sterile and Non-sterile operations at the Manati site. Ensures that appropriate GMP Quality Systems are in place and implemented in a sustainable manner, both through review and approval of procedures and shop floor presence, as required, and that adequate documentation exists to support and drive compliance. Ensures site GMP required procedures are in alignment and compliance with BMS Corporate Compliance and WWQ&C Headquarters Policies and Directives and verifies consistency with other site procedures and/or specifications and implemented in a complaint manner at all levels of the Organization Ensures adherence to the Quality unit responsibility (WWQC 2.1 current version) and provides leadership accordingly to the QA Unit. Ensures that deviations from procedures and specifications are investigated, resolved and documented; that corrective/preventative actions are identified and implemented to avoid the occurrence/recurrence of deviations that no materials are released before the completion of the investigation and that trends are identified and corrected before having negative impact to the Operation. Interfaces with Regulatory Agencies (FDA, EMA and foreign regulatory agencies) as necessary, leads site regulatory inspections and ensure compliance with the marketing authorization requirements.  Interfaces directly with suppliers and customers, as well as Global Product Development and Supply senior management. Ensures an effective process/system for disposition of raw materials, API’s, device components, packaging and labeling materials and the involvement in the decision for Bulk Drug Substances disposition. Core Member of the site Quality Council; ensures operations are conducted in compliance with established requirements. Monitor implementation plans for any new Quality Policies, Directives and associated impact assessments and verify compliance with BMS Policies and Guidelines. Ensures that all QA personnel have adequate training, education, and experience to perform their GMP related job functions effectively.  Educates staff on complex matters such as: contamination controls, root cause analysis, combination products controls, etc. Ensure the appropriate information to and obtain the Qualified Person’s approval as required by the specific European Union (EU) regulatory authorities is provided and that all products are manufactured per the approved specifications and filed parameters. Exercise sound judgment in making decisions and recommendations within generally defined practices and policies and notify senior management when necessary.  Works on abstract problems across functional areas of the business.  Identifies and evaluates fundamental issues for major functional areas through assessment of tangible variables.  Ensures budgets development and the preparation of periodic projections of spending against budgets; and manages and controls area spending. Direct involvement in securing regulatory filings of a facility or process and supports product submission documentation.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.