QA Manager

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.Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.