Quality Assurance Manager

3 days ago

New Brunswick, New Jersey, United States Bristol-Myers Squibb Full time
Transforming Patients' Lives through Science

Bristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled Quality Assurance Manager to join our team.

About the Role

The Quality Assurance Manager will be responsible for providing quality oversight for the selection of Contract Manufacturing Organizations (CMOs) used for the manufacture, bulk packaging, testing, and distribution of Clinical Supplies in accordance with corporate policies, procedures, and GMPs.

Key Responsibilities
  • Partner with Clinical Supply Operations (CSO) and Drug Product Development (DPD)/Chemical Product Development (CPD) to identify and qualify manufacturing facilities for the manufacture, bulk packaging, and testing of API and/or Clinical Drug Products.
  • Serve as the BMS Quality single point of contact for the assigned CMOs with responsibility for Quality and Compliance performance.
  • Ensure Deviations, Product Quality Complaints, Change Controls, Stability, and CAPAs are managed in a compliant and timely manner.
  • Oversee vendor change control process and ensure that BMS products are manufactured in full compliance with all applicable regulations.
  • Implement the process to achieve Vendor Quality Qualification with appropriate continued monitoring to ensure maintenance of status.
  • Partner with CSO/DPD/CPD to identify Quality and Compliance risks and develop/implement plans to mitigate via a risk management approach.
Requirements
  • BS/MS in a Scientific discipline, preferably in Chemistry, Pharmacy, 2-5 years' experience in the Pharmaceutical industry in a technical or quality role, and may be combined with other relevant Pharmaceutical industry experience.
  • Periods spent in clinical or commercial manufacturing operations would be considered advantageous.
  • Experience within a QA/QC environment is an asset.
  • Experience within R&D, including Chemical Development and/or Drug Product Development environment is an asset.
  • Experience in the manufacturing of non-sterile drug product and drug substance.
  • General knowledge of GMP operations and regulations.
What We Offer

Bristol Myers Squibb offers a competitive benefits package, including a wide variety of benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

We are an equal opportunity employer and welcome applications from qualified candidates without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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