Senior Director of Quality Operations
4 weeks ago
We are seeking an experienced Associate Director of Quality Operations to provide quality oversight for our biologics commercial programs.
The ideal candidate will have a strong background in GMP quality and experience managing complex business relationships with QPs/EU business partners.
Key Responsibilities- Ensure CMO compliance with applicable cGMP regulations, batch records, product registrations, quality agreements, and data integrity standards.
- Support QA batch record reviews and lot dispositions of commercial drug substance and drug product per established procedures for internal and business partner use.
- Lead quality aspects and provide support to our business partners on QA-related investigations, change controls, lot dispositions, and regulatory requests.
- Conduct and review product and/or lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs).
- Review and approve controlled documents, including commercial manufacturing and packaging master batch records, protocols, and final reports.
- Work with our Quality Systems and CMC teams to ensure quality and technical documentation is delivered to the internal archiving system.
- Provide guidance, advice, and support for GMP quality and compliance matters.
- Represent Quality as PIP at CMOs as necessary to support production operations.
- Demonstrate a high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
- University degree in life sciences or related fields.
- 5+ years' experience in GMP Quality in biopharma/biologics/pharmaceutical industry.
- Experience working directly with contract manufacturing organizations (CMOs) is required.
- Direct interaction with FDA, EMA, or other regulatory agencies during regulatory inspections and qualified persons (QPs) is required.
- Experience in biologics is required.
- Experience in sterile drug product manufacturing is preferred.
- Thorough knowledge of cGMP regulations.
- Experience supporting commercial and lifecycle management.
- Experience in oversight of contract manufacturing.
- Proficiency in electronic QMS Software such as Veeva, Trackwise, etc.
We are a rapidly growing biotherapeutics company with an approved drug on the market, leveraging scientific advances in B-cell biology to develop novel treatments for patients.
We offer a competitive salary, annual bonus, equity, 401(k) program, and remote work opportunities.
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