Senior Director, QC Operations

3 days ago

Devens, Massachusetts, United States Bristol-Myers Squibb Full time
Job Summary

This is a senior leadership role responsible for providing strategic direction and oversight to the QC Operations organization. The successful candidate will have a strong background in biopharmaceutical quality and experience leading large, multi-leveled organizations.

Key Responsibilities
  • Provide senior leadership to the QC Operations organization and oversee QC Analytical, QC Microbiology, and QC Systems activities.
  • Direct the daily operation of a QC organization to support the release of cell therapy products.
  • Define departmental roles and accountabilities, and hire, integrate, and develop high-quality talent.
  • Establish and communicate performance objectives for QC Operations staff and define performance measures.
  • Direct training and scheduling of QC Operations staff to ensure testing activities occur in an efficient and cGMP compliant manner.
  • Accountable for the efficient and timely technology transfer of test methods, new products, and new technologies.
  • Direct programs or procedures to ensure the proper qualification, calibration, operation, and maintenance of laboratory equipment.
  • Participate in site teams preparing for, hosting, and responding to regulatory inspections, reviews, and approvals.
Requirements
  • A minimum of 15 years in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility of a biologics, cell therapy, or drug product Quality Control laboratory or a related biopharmaceutical industry.
  • Experience leading and managing a large, multi-leveled organization is essential.
  • In-depth knowledge of common QC procedures, techniques, and laboratory equipment/instrumentation, and the application and interpretation of GMP concepts and compendia requirements.
  • Proficiency in analytical assay methodologies such as molecular biology and flow cytometry assays.
  • Proficiency in microbiological assays such as sterility and endotoxin.
  • Demonstrated leadership, interpersonal, communication, and motivation skills.
  • Knowledge of cell therapy or biologics manufacturing is highly desirable.
  • Extensive knowledge of US and EU cGMP regulations and guidance.
  • Extensive and proven experience in FDA (or other regulatory authority) inspection preparation and management is essential.

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, 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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