QA Manager - Manufacturing Support

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.

Principal Objective of the Position

Provide Quality oversight during Clinical Supply Operations drug product and packaging and labeling manufacturing activities, and other GMP support areas.

Provide Quality on the floor in-Process support during manufacturing operations.

Assure the quality of manufactured products complies with all applicable regulations and guidelines. Performs monitoring and assessment of the Clinical Supply Operations areas to ensure compliance with all principle of current Good Manufacturing Practices (cGMP).

Key Responsibilities and Major Duties

Perform monitoring/walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs.

Perform documented periodic assessment of Clinical Supply Operations for Global Audit and Regulatory Agency inspection readiness.

Develop and manage responsibilities for the In-process Control QC/QA activities conducted during manufacturing activities (e.g. Line Clearance, AQL inspections).

Monitors and trends observations and CAPAs to ensure compliance with cGMP regulations and BMS procedures.

Provides instruction and guidance on quality issues and serves as a resource for the site. Supports site operations during regulatory agency and third party inspections.

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Experience - Responsibility and minimum number of years

• Minimum B.S. in related sciences.
• A Ph.D. in a related science with 4-6 years of relevant experience within the pharmaceutical or healthcare industry, or a M.S. with 7-9 years experience, or a B.S. with 9-11 years experience; including 3-5 years experience in a regulated function.
• Experience within a QA/QC environment is an asset.
• Experience within R&D environment is an asset.
• Broad experience in the manufacturing of sterile and non-sterile products.
• In-depth knowledge of GMP regulations
• Strong interpersonal and organizational skills
• Demonstrated leadership skills
• Effective written and verbal communication

Computer literacy: Microsoft Office and SAP environment, Quality Management System, PDLIMs, and other systems as required (eg DeltaV, Pilotclean)

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.