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.
Purpose/Objective of the job
· Conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits as above described.
· Act as project-specific liaison between R&D Quality - CT&S and key stakeholders, including Global Clinical Operations and Global Regulatory, Safety & Biometrics (GRSB) personnel, monitoring the status of the project(s) to plan audits and assuring GQ - CT&S leadership as informed.
· Represent GQ-CT&S as an expert in specific GCP/PV related areas
Key Responsibilities and Major Duties
· Within multiple areas of GCP/PV expertise, act as an expert resource;trainer for GQ-CT&S and as liaison with key stakeholders to provide input into related audit strategy and plans
· Within areas of expertise, maintain awareness of trends and new developments internally and externally
· Perform GCP and PV audits, including audits of clinical investigator sites, vendors, internal systems and clinical study reports to assess regulatory compliance;
· Apply audit principles, procedures, and methods; Collect information through effective interviewing, listening, observing and reviewing documents, records and data;
· Prioritize and focus on matters of significance;
· Confirm the sufficiency and appropriateness of audit evidence to support audit findings and conclusions;
· Assess those factors that may affect the reliability of the audit findings and conclusions;
· Prepare clearly-written, concise, accurate and evidence-based audit report;
· Maintain audit database
· Review and assess (or support the review) received corrective and preventive action plans according to specified timelines to ensure resolution of audit findings and prevent recurrence.
· Maintain an in-depth knowledge of governmental regulations impacting clinical research and PV and development of medicines.
· Provide advice and counsel concerning GCP regulatory requirements.
· Act as project-specific liaison (Project Coordinator) and provide input into audit plans and strategy.
· Regularly evaluate key PV and clinical research processes to determine compliance with regulatory requirements and established standard operating procedures.
· May provide mentoring for new GQ-CT&S staff, as needed.
· Support upper management on the on-boarding of new hires
· Represent GQ-CT&S position during internal and external meetings
· Lead project related teams or workstreams as assigned
· Act as an advisor and back up to the Director
· Coordinate health authority inspections as assigned and maintain inspection tools repository
Key Stakeholders/Contacts -
· Regular contact and collaboration with Global Quality CT&S strategy roles, GQ and Clinical Quality governance (risk management and CAPA), colleagues/co-auditors located globally;
· Contact with appropriate technical, supervisory and management personnel internally and externally (investigator sites, vendors, etc.) in the conduct and reporting of audits.
· Regular collaboration with GQ-CT&S colleagues and with GCO and GRSB personnel
· Possible interactions with external auditors and Regulatory Agency inspectors during the conduct of health authority inspections either at clinical sites or at BMS facilities.
· Miscellaneous contacts as assigned by GQ-CT&S management
List of minimum requirements
o Bachelor´s degree required - Life Sciences degree preferred
o Experience/Responsibility and minimum # of years:
o Demonstrated expertise and specific technical knowledge of the GCP and PV areas subject to audit, as evidenced by at Ieast 8 years in the pharmaceutical industry
o Minimum 5 years technical auditing and/or related experience; PV and GCP auditing preferred
o Strong skill in risk based prioritization
o Strong critical thinking to analyze complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions;
o Excellent understanding of the drug development process and end to end quality process
o Support GQ-CT&S management on identification of areas to increase department efficiency
o Demonstrates computer literacy and is able to function independently within an environment that relied heavily on technology for information and communication
o Excellent oral and written communication;
o Fluent in English (and other languages, as applicable to assigned audit region);
o Sense of diplomacy and discretion;
o Maintains the confidentiality and security of information, data and records;
o Demonstrates commitment to delivering high-quality work product;
o Knowledge of governmental regulations impacting clinical research and drug development
o Understand the appropriateness and consequences of using sampling techniques for auditing;
o Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective;
o Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment;
o Develops strong working relationships with key stakeholders;
o Ability to manage competing priorities.
o Ability to lead change process within functional group
o Possesses detailed knowledge of areas of expertise and could teach or mentor others
o Develops and applies new methods and ideas to enhance performance
BMS Behaviors and Working conditions:
o BMS Biopharma Behaviors required: Passion, Accountability, Innovation, Speed
o Travel Required (nature and frequency) approximately 25% travel to perform audits and attend professional meetings and seminars.
o Overnight Absences Required (per typical month): Approximately 5 days per month
Software that must be used independently and without assistance (e.g., Microsoft Suite, Electronic Trial Master File, Oracle clinical database, RAVE, Trackwise, Sharepoint, etc
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.