Associate Director of Quality Operations

2 hours 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. This role will provide laboratory QA support for our biologics commercial and clinical development programs by working closely with our various contract development and manufacturing organizations.

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 across clinical and commercial CMC programs.
  • Capture of records in Veeva for QMS activity at CDMO/CTLs, including quality events, deviations, investigations, OOS/OOT, CAPA, and Effectiveness checks.
  • Collaboration with Analytical Development group as needed, seeking additional technical support for test method implementation, troubleshooting, performance monitoring, and OOS/OOT investigations.
  • Drive change management in Veeva for implementation and modification of Quality testing related lifecycle documents.
  • 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, stability protocols/reports.
  • Review of analytical method transfer/validation protocols, reports, and implementation plans.
  • Author and/or review APQRs, CTD sections of regulatory submissions, supplements, variations, and updates.
  • Ensure critical reagents and reference standards are qualified and adequately supplied for clinical and commercial CMC programs.
  • Maintain compliant data integrity practices for document originated by CDMO/CTLs.
  • Participate in supplier qualification audits, due diligence, and/or health authority inspections of CDMO/CTLs.
  • Support product complaints, stock recovery/product recall, field alert, and other quality events and regulatory actions as needed.
  • Author and/or review content of CDMO/CTL Quality Agreements.
  • Travel approximately 10% of the time (domestic and international).
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.
  • Knowledge and expertise in principles and practices of cGMP for biologic drug substance, drug product, and/or aseptic manufacturing experience is a plus.
  • Experience with CMO / CTO management (e.g. worked with or for CMOs / CTOs).
  • 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.
  • Direct interaction with FDA, EMA, or other regulatory agencies during regulatory inspections is a plus.
  • Demonstrated ability to broadly assess regulatory compliance audit findings and implement appropriate CAPAs at CMOs / CTOs.
  • Experience with assessing validation requirements for laboratory, facilities, and equipment.
  • The ability to manage multiple priorities with aggressive timelines and changing priorities.

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