What are the responsibilities and job description for the GMP Associate Director position at Meet?
A clinical-stage biotechnology company in South San Francisco is seeking an Associate Director of CGMP Quality Assurance. This role reports directly to the Head of Quality and plays a crucial part in managing external vendors and CDMOs, while contributing to the development and maintenance of quality systems. The ideal candidate will have deep expertise in CGMP regulations, a proactive approach to quality management, and the ability to foster a culture of ethics and integrity.
Key Responsibilities :
- Serve as the technical expert on CGMP regulations for manufacturing, testing, and controls.
- Review and approve manufacturing, packaging, and labeling documents for drug substances and products within established timelines.
- Lead external quality activities including batch record reviews, analytical method validations, tech transfers, deviations, quality agreements, supplier qualifications, and audits.
- Participate in CDMO team meetings, offering quality feedback and collaborating on complex investigations for the global product network.
- Collect, review, and analyze data for internal and external quality metrics.
- Provide guidance and assessments for change controls and CAPAs.
- Implement CGMP and GLP activities in accordance with internal procedures and regulatory standards.
- Participate in quality system and product review meetings, ensuring data integrity and compliance.
- Represent the Quality department in project teams, health authority inspections, and supplier / CDMO meetings.
- Collaborate with the Quality Person (QP) to develop and approve key documents.
- Gain hands-on experience with GCP-focused projects, including potential auditing activities.
- Promote a strong quality mindset and culture of collaboration aligned with company values.
Qualifications :
Education & Experience :
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science, Accounting / Auditing, and Research
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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