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Associate Director of Quality Operations
2 months ago
We are seeking an experienced Associate Director of Quality Operations to join our team at Jobot. As a key member of our Quality Operations team, you will be responsible for providing laboratory QA support for our biologics commercial and clinical development programs.
Key Responsibilities- Vendor management of contract laboratories, including routine external meetings, coordination of testing results, and issue resolution.
- Review of testing execution by CDMOs/CTLs, generation of internal COAs, and response to emerging trend performance of drug substance and drug product.
- Capture of records in Veeva for QMS activity at CDMO/CTLs, including quality events, deviations, investigations, and CAPAs.
- Collaboration with Analytical Development group as needed, seeking additional technical support for test method implementation, troubleshooting, and performance monitoring.
- Design and lead new initiatives and process improvements to Laboratory QA processes, including business tools, escalation norms, and communication pieces.
- Author, review, or approve lifecycle documents governing the Laboratory QA function, including SOPs, analytical methods, specifications, and stability protocols.
- University degree in life sciences or related fields.
- 10+ years' experience in GMP Quality/QA/Quality Systems/ or Analytical Development in the biopharma/biologics/pharma industry.
- Experience with data integrity assessments or remediation within an organization or at CMOs / CTOs.
- Hands-on experience in providing Analytical, QC or Microbiology support for clinical and commercial manufacturing, tech transfers, product launches, and ongoing commercial supplies.
- Broad working knowledge of global regulations for manufacturing, testing, packaging, and distributing drug substances and drug products.
We offer a competitive salary, annual bonus, equity, 401k program, remote work option, and health benefits. If you are a motivated and experienced professional looking for a new challenge, please apply now by clicking the "Apply" button.