QA Manager - Analytical Laboratory 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.

Summary:

• Provide Quality oversight for testing of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures.

• Coordinates the assignment of tasks to be performed by the assigned managers/Associates/Specialists.

• Assure the quality of manufactured products complies with all applicable regulations and guidelines.

Responsibilities:

• Conducts, plans, schedules, or supervises the review and approval of laboratory data, and other documentation as needed.
• Reviews and approves documents related to Quality Systems such as laboratory investigation reports (OOA, OOS), test method validation protocols or reports, test specifications, SOPs/WIs, change controls, raw material release, etc.
• Drafts and/or reviews Quality Agreements, as requested.
• Supports site operations during regulatory agency and third party inspections.
• Provides on-the-job training to Quality Operations personnel and GMP training to functional areas, as appropriate.
• Brings to the attention of the Quality Operations Management, any information relating to the impact of legislation on the functions of the department, system deviations, etc.
• Provides reports to Management related to timely CAPA implementation, as requested.
• Provides support to PD/DPST-Device Operations for overall quality system and review of protocols and procedures, as requested.
• Build and foster strong relationships and partnerships with stakeholders and support groups to meet the demands of a changing business culture and environment.
• Provides instruction and guidance on quality issues and serves as a resource for the site.
• Adherence to BMS core behaviors

Professional experience and qualifications

• Knowledge of science generally attained through studies resulting in B.S. or M.S. in chemistry, pharmacy or biology or a related pharmaceutical science
• 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.
• Knowledge of biopharmaceutical analytical methods
• Experience within a QA/QC environment is required
• Technical expertise in resolution of deviations and development of effective CAPA
• Experience in Quality Management at development and/or commercial stage of pharmaceutical operations
• Broad experience in the manufacturing of sterile and non-sterile products
• In-depth knowledge of GMP regulations
• Strong problem solving, interpersonal and organizational skills
• Strong collaborative and influencing skills
• Effective written and verbal communication
• Computer literacy: Microsoft Office and SAP environment Trackwise®, PDLIMs, and other systems as required

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.