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Associate Director, Quality Operations Lead
1 month ago
We are seeking an experienced Associate Director of Quality Operations to join our team at Jobot. In this role, 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 production of batch analysis and stability tables.
- 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 (i.e. ICH guidance, FDA/EMEA GMP regulations, etc.) for manufacturing, testing, packaging, and distributing drug substances and drug products.
