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At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

POSITION SUMMARY:

Report to: Head of Risk management Group, Drug Safety

PRINCIPAL RESPONSIBILITIES:

Responsible for:

• To ensure benefit-risk balance across the product lifecycle for Celgene KK products (drugs and regenerative products) by executing appropriate safety measures.
• To keep the safety of the subject in clinical studies.
• To contribute NDA activities from the safety perspective for the patients’ early and appropriate access to the drugs / regenerative products.
• To ensure excellent regulatory compliance and credibility.

Key Activities

◆ Risk management

1. Safety review and signal detection for drugs and regenerative product and proposing the safety communication to the site including the revision of the materials

2. Preparation and submission of initial and updated J-RMPs (including the discussion with Global team and negotiation with PMDA.)

3. Drafting and updating the precautions in J-PI

4. Review the safety part of the documents of clinical studies (Protocol, ICF, IB, CSR, etc.)

5. Authoring the response to the inquiries from PMDA for NDA and Post-marketing phase

6. Preparation of materials for proper use (Proper use guide, Patient leaflet, Interim/ Final report of EPPV, etc.)

7. Provision and communication of information on proper use

8. Planning and conducting EPPV.

9. Drafting the Plan of Safety assurance measures and perform the measures

10. Prepare the application for Re-examination and re-evaluation

◆ Preparation of the report

1. Preparation and submission of periodic reports (J-DSUR and Non-serious unexpected adverse reactions report) to PMDA. Drafting the part of safety part of J-PSUR.

2. Preparation and submission of the EPPV report to PMDA.

3. Preparation and submission of the Research report and Safety measure report to PMDA.

4. Prepare the application for Re-examination and re-evaluation

◆ Collaborate with other functions

1. Support the clinical study team from safety perspective

2. Training to Celgene KK staff on product safety profile and risk minimization measures.

3. Contribute to ensure the benefit-risk profiles.

◆ Improve safety control activities to enhance maintenance of compliance

1. Monitor the changes in regulations and evaluate the impact on local processes.

2. Make effort to improve the safety vigilance procedure and in interactions with other department and Global Drug Safety and Risk Management (GDSRM).

3. Ensure the awareness of changes in regulations and evaluate the impact on local processes related risk management.

4. Take initiatives in improvement of the safety vigilance procedure and in interactions with other departments and GDSRM.

Key Relationships

◆ Outside the Company

1. Authorities (MHLW, PMDA)

2. KOLs of the safety advisory board, etc.

3. Vendors

4. Other companies

◆ Within the Company

1. All Department of Celgene KK, especially NDA project team, Regulatory Affairs, Medical Affairs and Sales & Marketing, in relation to Drug Safety.

2. Global Drug Safety and Risk Management

Preferred Role Qualifications, Experience, Knowledge & Competencies

◆ Qualifications

1. Minimum of B.S. or the equivalent education in life science

2. Frequent in Japanese and English (TOEIC>900 or equivalent) with ability to work in global context

◆ Experience

1. Ten (10) years pharmaceutical/biotechnology industry experience

2. Ten (10) years drug safety experience (drug safety is mandatory; safety of the medical device and regenerative products is preferable)

3. Clinical experience preferred (especially for hematology and oncology)

4. Management experience preferred

◆ Knowledge

Pharmaceutical and Science background (especially for hematology and oncology) Mastery of global / local Pharmacovigilance/safety regulatory requirement (Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulations, GCP, GVP, GPSP, etc.) Proficiency in safety processing (GVP-SOP, Global SOP, etc.) Issue management for safety

◆ Competencies

1. Group Leadership

2. Communication/ cross-functional collaboration skill

3. Negotiation skills

4. Scientific/Technical thinking

5. Networking (International)

6. Decision Making

7. Presentation skills

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary

Primary internal customer interface for service delivery of outsourced facility services and self performed facility services.  Full knowledge of supplier agreement in both contract compliance and execution, including ongoing relationships with suppliers.  Operational knowledge of formulating, implementing and supervising fire safety plans that take care of specific fire and life safety systems . 

This position will report to the Site EHS Director as a member of the Site Leadership Team. 

Responsibilities include

• Primary interface with service provider for service delivery. 
• Drafting and updating emergency plans and evacuation procedures.
• Overseeing Fire Prevention and other safety systems.
• Frequent contact with managers/employees in other departments and/or customer representatives to coordinate activities concerning operational decisions and business requirements. 
• Ensures the interests of the customer are primary; acts as champion for customer. 
• Support development and management of site operating budget.
• Provides leadership, guidance and problem-solving skills to employees either within the department or through project/process coordination. 
• Performs work, conducting activities and solving difficult or unusual problems. 
• Enforce safety codes and regulations/guidelines within organization.    
• Develop and assure compliance with department SOPs, EHS policies and procedures including corporate/division policies.       
• Responsible for site auditing as it relates to environment, health and safety in partnership with site EHS. 
• Management of “out of scope” contracts supporting site operations.
• Oversight for service provider outcomes; reviews site CPI/KPI/GPI where applicable. 
• Coordinate site emergency response. 
• Administers company policies by making decisions on matters of day-to-day implementation and interpretation.  Must be able to influence others.  
• May be required to support other sites in the region.

Requirements/Education

• BS Degree or equivalent experience desired. 
• Minimum of seven years experience in operations, maintenance and service, fire and life safety systems,   
• Hands on experience in the procurement, negotiation, and management of contracts with maintenance suppliers, contractors and consultants.
• Broad Technical knowledge of facility operations, infrastructure, engineering and systems.
• High level of interpersonal, communication and presentational skills.
• Demonstrates strong leadership skills, sound business ethics, and ability to work in a team environment.
• Knowledge of pharmaceutical regulations and industry practices such as environmental regulations, building codes, ADA and OSHA requirements.
• Experience in managing the financial aspects of facility operations and services including budget development, expense forecasting, SAP transactions and cost tracking. 
• Ability to identify and solve technical problems in very complex research systems.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologic products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); &/or post-approval submissions.

In this role, the GRS-CMC Associate Director, Biologics will serve as the primary interface between Global Regulatory and Saftey Sciences (GRS) & Global Product Supply (GPS).  The GRS-CMC Associate Director will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.

Position Responsibilities

• Represent regulatory CMC on and/or lead matrix teams for biologic pipeline products and/or commercial products through completion of post-marketing commitments & relevant lifecycle management projects driven by research

• Independently provide strategic guidance/input related to current regulatory requirements and expectation for cell therapy marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.

• Independently manage and prioritize multiple complex projects

• Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.

• Identify, communicate and propose resolutions to routine/complex issues

• Interpret global regulations and guidance. Identify regulatory opportunity and risks.

• Anticipate and communicate possible regulatory paradigm shifts

• Participate in product fact finding meetings

• Review and provide regulatory assessments on change controls

• Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents

• Mange relationships with diverse teams

• Utilize electronic systems for dossier creation and tracking.

Qualifications

• Minimum BA/BS Degree (Masters or higher preferred) and 7-10+ years Pharmaceutical industry experience – prefer knowledge of biotechnology products, including multi-disciplined experience, 6+ years CMC regulatory strategy (biologics experience preferred).

• Knowledge of CMC regulatory requirements during development and post-approval.   Experience with global CMC regulations for biological compounds preferred.

• Knowledge of biopharmaceutical development, including biological drug substance and sterile drug product and analytical methods. Expertise in the biologic drug development process and analytical methods, preferred.

• Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.

• Ability to identify, communicate and resolve complex issues.

• Prepare and manage filings and ensure thoroughness, accuracy and timeliness.

• Ability to interpret global regulations and guidance.

• Strong oral and written skills.

• Proficient with electronic systems

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Responsibilities

• Responsible for the development of the CMC regulatory strategy for submissions.  These submissions include IND/CTA, NDA, CTD and MAA regulatory filings. 

• Collaborate with other relevant line functions to prepare and review CMC submission documents, registration dossiers, and responses to health authorities.

• Responsible for the regulatory evaluation of CMC change controls.

• Responsible for the management of CMC activities related to specific developmental or commercial compounds.

• Represent Regulatory CMC on CMC development/commercial and Regulatory Affairs teams. 

• In addition take on leadership role in the CMC development/commercial teams. Interact with regulatory agencies and represent CMC at regulatory agency meetings.

Qualification/ Skills / Knowledge Required

• BS/BA degree in Scientific Discipline (Masters or higher preferred) with 7-9 years in the pharmaceutical industry or in CRO, including 4-6 years’ CMC regulatory experience.

• Must have experience with CMC regulatory documents (NDA, MAA, CTD, annual reports, supplements, responses and IND/CTAs)

• Knowledge of FDA, EMEA and ICH guidelines

• Have a solution-oriented approach to problem solving

• Experience in developing CMC regulatory strategy

• Expertise in either the drug development process or post approval activities

• Ability to work on complex projects and within cross-functional teams

• Excellent grammar and communication skills, both written and oral

• Prior supervisor or project management experience

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary:

Lead the development and execution of comprehensive, globally aligned Patient Safety publication plans to support the effective communication of research advancing the science of pharmacovigilance, epidemiology and risk management, along with safety data on BMS medicines. Ensures efficient planning, tracking and timely dissemination of key scientific and technical data through quality external communication deliverables including but not limited to manuscripts, abstracts, oral presentations, posters and publication summaries. Proactively seeks and establishes strong partnerships with WWPS colleagues and cross-functional stakeholders, ensuring expert input into publications strategy and content deliverables, and providing clear and concise status updates.

Provides direction to communication agencies, medical writers, and/or consultants involved in the development of publications; must ensure timely and cost-effective outputs in keeping with financial and service agreements. Must demonstrate proficiency in scientific content development, with ability to interpret scientific/clinical/technical and pharmacovigilance data for development of quality publications.

This role sits within the newly formed Business Capabilities & Innovation (BCI) function within WWPS and will be responsible for maturing scientific publications as a core capability within WWPS. The incumbent will also be responsible for the development and design of internal and external communications deliverables in keeping with WWPS communication objectives. Must be comfortable managing multiple high priority projects, working with ambiguity and display confidence in building new standards and aligned ways of working with and across a diverse set of stakeholders across the organization.

Core Responsibilities:

• Develop standards, operating procedures, tools and templates for Publications Management within WWPS, ensuring alignment with corporate policies, industry regulations, and compliance requirements

• Develop and maintain WWPS publications strategy and tactical plan in support of WWPS mission and goals, ensuring alignment with cross-functional stakeholders (GDD, Medical Affairs, Medical Capabilities)

• Perform literature gap analyses to feed into the WWPS research and innovation strategy

• Track development and delivery of publications body of work, and communicate progress and decisions clearly and regularly to internal and external stakeholders

• Develop and deliver publications training for WWPS colleagues

• Develop and review manuscripts, abstracts, posters, presentations, and scientific communications to ensure appropriate evaluation and presentation of data, methodology, interpretation, and alliance with business/communication objectives.  Ensure content meets standards for quality, credibility and clarity

• Interpret, synthesize and communicate complex scientific and business data both internally and externally to advance understanding and to support evidence-based decisions

• Support development and tracking of departmental publications and conference budget

• Support resource planning to drive execution of publication goals

• Provide direction to and oversee the deliverables of agencies, vendors and/or contracted staff to support literature gap analysis and content creation (abstracts, posters, oral presentations, manuscripts, etc); responsible for ensuring quality, timely, and cost-effective outputs

• Establish partnerships with external thought leaders, industry leaders, and professional societies in a proactive manner in order to drive current and future collaborations

• Develop and maintain calendar of professional and scientific conferences, seminars, industry fora, and support conference planning across WWPS

• Create and deploy pre- and post-conference toolkits for attendees (includes conference overview, abstracts of interest, summary of WWPS presentations, Q&A)

• Ensure communication of conference insights through different communication channels to WWPS (eg, newsletters, WWPS chats, etc); leverage insights to inform additional scientific publication deliverables

• Develop and maintain repository of medical and technical journals and requirements; support authors in target conference and journal selection

• Define, monitor and report metrics and key performance indicators for WWPS publications management capability (ex. Downloads, conference acceptances, impact and engagement metrics); generate analytic reports related to publication projects and communicate with WWPS stakeholders and leadership

• Serve as internal subject matter expert on good publication practice and WWPS standards, supporting internal and external authors in the content development and review process  

• Drive internal and external communications planning and execution of deliverables as part of Business Capabilities and Innovation function as required, in collaboration with BCI Strategy & Engagement Lead, WWPS stakeholders, and Corporate Communications colleagues

• May be responsible for design and conduct of research falling within the scope of the Business Capabilities and Innovation function

Other Responsibilities:

• Conducts business in accordance with BMS Values.  Completes all assigned SOPs and training within designated timeframe and adheres to job-specific SOPs and work instructions

• Support hiring, training, mentorship and development of staff within BCI and WWPS as needed

• Participates in external meetings/seminars and/or internal learning and development programs to enhance professional skillset, therapeutic area knowledge, and broaden pharmaceutical industry experience

• Lead and/or contribute to BCI and/or WWPS strategic initiatives to support individual and organizational development

Key Relationships:

• Sr. Director, Business Capabilities and Innovation

• Sr. Director, PV Innovation

• Head, Epidemiology, Safety Science, Capabilities and Innovation

• Worldwide Patient Safety Leadership Team

• Worldwide Patient Safety colleagues, globally

• Medical Capabilities

• Medical Affairs

• Global Drug Development

• Corporate Legal

• Regulatory Affairs

• Corporate Communications

Qualifications

• Bachelor's or advanced degree (eg, MS, PhD, MD or PharmD) in science, medicine, pharmacy, or other allied health field required.

• Minimum of 3-5 years of experience in the pharmaceutical or life science industry required.

• Experience with publications/scientific communications development required.

Skills/Knowledge Required:

• Experience with publications planning and execution, including target journal and conference selection, journal submission and review process, etc.

• Knowledge of external guidance and best practices including good publication practice, ICMJE requirements, etc.

• Experience with publication and/or content management tools preferred (eg, Veeva, Datavision, etc)

• Understanding of research methodology, drug development, clinical study data and outcomes measures, and data analysis; ability to translate scientific and technical data for diverse audiences

• Project management and budget skills, with demonstrated ability to plan, prioritize and execute multiple projects, and to solve problems working with multidisciplinary teams.

• Demonstrated personal and scientific credibility to engage with global external experts recognized as leaders in their field.

• Self-starter who is willing and able to work independently

• Demonstrates a high level of intellectual curiosity, coupled with critical thinking to analyze information and translate meaningful insights relevant to our business and strategic initiatives

• Excellent writing and presentation skills, tailoring deliverables to align with target audience needs

• Demonstrated ability to lead and collaborate effectively within a multi-disciplinary team

• Demonstrates strong understanding of industry trends, regulations, and market dynamics that may affect the practice of PV globally

• High level of organization and attention to detail

• Good influencing skills to generate stakeholder commitment to scientific communications

• Flexibility of approach, a positive attitude, and strong ability to communicate at all levels within the company

• Some travel may be required to represent company at medical conferences, presentations, and other meetings

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Manager/Engineer of External Manufacturing Technology will provide technical support for manufacturing of BMS parenteral drug products at Contract Manufacturing Organizations (CMO’s) in the US,  EU, and abroad.  The individual will act as single point of contact for technical matters at the CMO, and may perform Person in Plant duties (PIP) in support of technical transfer and commercial manufacturing activities. 

This position will report into the Associate Director of Biologics Drug Product External Manufacturing located in Boudry, Switzerland. This position will be located in Boudry, Switzerland.

Key Responsibilities

• Participation in CMO/vendor selection with Procurement, Quality, and other business functions. 
• Technical single point of contact and BMS Site Implementation Lead to contract manufacturing organizations in support of technical transfers. This includes review and approval of site technology documents such as Engineering Studies, characterization Protocols, Validation Protocols, Process Risk assessments, etc.  This likely will include Person in Plant (PIP) support
• Execution of Process Owner Role at contract manufacturing sites.  This includes process capability analysis and Continuous Process Verification of key quality attributes and parameters at the CMO , identifying and executing process robustness improvement projects where required. Use of this knowledge to ensure timely, comprehensive and accurate process data reviews and to support generation of Annual Product Quality Review documents for commercial products.
• Leadership or support of critical manufacturing or complaint investigations that involve significant product impact including root cause analysis, CAPA generation, and impact assessment
• Technical input, authoring, and approval of CMC documents, support CMC query resolution with Global Health Authorities, and support of plant inspections.
• Participation on matrixed Technical Product Teams to drive technical process improvement strategies.  Must generate presentations to support development, approval, and execution of technical plans. Employment of resources and processes (OPEX etc) to improve processing efficiency and to ensure optimized technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.

Knowledge/ Skills

Education:

• A bachelor’s degree in relevant engineering or science discipline (chemical/mechanical/bioprocess engineering, biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required. Masters or PhD level degree is preferred.

Experience / Knowledge Desired:

• Strong technical knowledge (subject matter expert) of sterile manufacturing processes and technology, with a minimum of 4 years of experience preferably in a manufacturing plant and/or secondarily in a manufacturing, science, and technology department.
• Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
• Experience with the execution of Technology Transfer and scale up programs for commercial drug product manufacturing processes.
• Strong technical writing skills and ability to design, author, and execute process development, qualification and validation protocols (e.g. PPQ) consistent with current Global Health Authority requirements.   
• Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone, as well as statistical analysis knowledge

Requires approximately 25-35% travel, mostly to CMO sites and includes international.  May require Person in Plant (PIP) temporary assignments, where location at site is up to 75% for a temporary time period

Personal Competencies Desired/Required:

• Strong strategic and analytical thinking, problem solving and rapid decision making skills
• Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous matrix environment
• Strong ability in negotiating and influencing without authority in complex, high impact situations
• Strong presentation and communication skills both, oral and written

BMS Bio-Pharma Behaviours Required:

ACCOUNTABILITY: We own our outcomes and the outcomes of others

SPEED: We act with urgency and agility

INNOVATION: We embrace new ideas

PASSION - We pursue excellence to help patients prevail

*d stands for diverse, meaning that BMS welcomes every employee independent of gender, age, sexual orientation, ethnicity, religion

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Responsabilities:

• Proactively manage Third Party Manufacturer and Alliance Partnership relationships from a quality and compliance perspective
• Develop and manage the quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships
• Actively support the BMS Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products. Prepare and present the information to senior management in support of the FF/PRC processes
• Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MS&T teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs etc.
• Provide the requisite quality support to Global BMS functional groups such as Global Regulatory/CMC and the local country-based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions etc.
• Manage the quality metrics programs in relation to Contract Manufacturing Organization and VPT performance
• Serve as the Quality Operations leader in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties
• Prepare, negotiate and approve Quality Agreements with the Third Party Manufacturers and Alliance Partners
• Review and approve the Annual Product Quality Reviews submitted by the Third Party Manufacturers
• Support the Global BMS external auditing program by participation in audits of Third Parties as requested
• Select and retain Quality employees on VPTs
• Allocate resources such that the right person is doing the right work at the right time
• Review and approve goals and objectives for direct reports
• Proactively develop and mentor staff

Required Competencies:

• In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
• Ability to assess the right balance between business targets and scientific and quality decisions
• Ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers
• Strong negotiation, communication and presentation skills across all levels both internal and external to BMS
• Strong analytical and problem-solving skills

Required Qualifications:

• BSc or equivalent in scientific discipline
• Five to ten years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency
• Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
• Direct experience interacting with Health Authorities and managing Health Authority inspections, specifically FDA and/or EMA
• Direct experience in interacting with external manufacturers and managing quality at external manufacturing sites
• The Qualified Person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products