Job Description

The Senior Manager of Quality Assurance oversees QA support for daily operations within the QC, Analytical, and Microbiology laboratories, ensuring all testing meets cGMP standards and regulatory requirements. This role manages a team of QA professionals and provides quality oversight of data review, lab investigations, and compliance with data integrity principles. The manager is also responsible for key quality systems such as batch review, product release, deviations, CAPAs, and change control, while aligning QA resources to meet production and client timelines.

Qualifications:

• Bachelor’s degree in a Science or Engineering discipline.
• Minimum of 10 years of experience in Quality Operations within biotechnology, biologics, or pharmaceutical manufacturing, including at least 5 years focused on QA oversight of Quality Control laboratory functions.
• At least 8 years of leadership or management experience in a quality setting.
• Proven experience with drug product quality and strong background in biologics production and materials/components.
• In-depth understanding of cGMP regulations (US, EU, Canada, Japan) and quality systems including Deviation, CAPA, OOS, Change Control, Document Control, Testing Review and Release, and Supplier Quality.
• Comprehensive experience across all QC testing areas—utilities, raw materials, in-process, and final product.
• Strong decision-making skills with effective use of risk management tools.
• Familiarity with manufacturing processes, laboratory operations, and critical systems.
• Experience with continuous improvement tools; certifications such as ASQ, Six Sigma Green Belt, or Lean preferred.

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