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Associate Director of Quality Operations

2 months ago


Durham, North Carolina, United States Jobot Full time
Job Summary

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.
Requirements
  • 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.
What We Offer

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.