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Director of Quality Operations

2 months ago

Durham, North Carolina, United States Jobot Full time
About the Role

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: Manage contract laboratories, facilitate routine external meetings, coordinate planning and delivery of testing results, lead implementation, and manage issue resolution.
  • Testing Execution: Review testing execution by CDMOs/CTLs, generate internal COAs, produce batch analysis and stability tables, and respond to emerging trend performance of drug substance and drug product across clinical and commercial CMC programs.
  • Record Management: Capture records in Veeva for QMS activity at CDMO/CTLs, such as quality events, deviations, investigations, OOS/OOT, CAPA, Effectiveness checks, etc.
  • Collaboration: Collaborate with Analytical Development group as needed, seeking additional technical support for test method implementation, troubleshooting, performance monitoring, and OOS/OOT investigations.
  • Change Management: Drive change management in Veeva for implementation and modification of Quality testing related lifecycle documents (i.e. test methods, specifications, stability protocols, and related technical documents).
  • Process Improvement: Design and lead new initiatives and process improvements to Laboratory QA processes, including business tools, escalation norms, communication pieces.
  • Document Authorship: Author, review, or approve lifecycle documents governing the Laboratory QA function, including SOPs, analytical methods, specifications, stability protocols/reports.
  • Method Transfer: Review analytical method transfer/validation protocols, reports, and implementation plans.
  • Regulatory Compliance: Author and/or review APQRs, CTD sections of regulatory submissions, supplements, variations, and updates (e.g. BLA, IND, MAA, IMPD).
  • Critical Reagents: Ensure critical reagents and reference standards are qualified and adequately supplied for clinical and commercial CMC programs.
  • Data Integrity: Maintain compliant data integrity practices for document originated by CDMO/CTLs.
  • Supplier Qualification: Participate in supplier qualification audits, due diligence, and/or health authority inspections of CDMO/CTLs.
  • Quality Events: Support product complaints, stock recovery/product recall, field alert and other quality events and regulatory actions as needed.
  • Quality Agreements: Author and/or review content of CDMO/CTL Quality Agreements.
Requirements
  • Education: University degree in life sciences or related fields.
  • Experience: 10+ years' experience in GMP Quality/QA/Quality Systems/ or Analytical Development in the biopharma/biologics/pharma industry.
  • Data Integrity: Experience with data integrity assessments or remediation within an organization or at CMOs / CTOs.
  • Analytical Support: Hands-on experience in providing Analytical, QC or Microbiology support for clinical and commercial manufacturing, tech transfers, product launches and ongoing commercial supplies.
  • cGMP Knowledge: Knowledge and expertise in principles and practices of cGMP for biologic drug substance, drug product and/or aseptic manufacturing experience is a plus.
  • CMO Management: Experience with CMO / CTO management (e.g. worked with or for CMOs / CTOs).
  • Regulatory Knowledge: 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.
  • Regulatory Interaction: Direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus.
  • Regulatory Compliance: Demonstrated ability to broadly assess regulatory compliance audit findings and implement appropriate CAPAs at CMOs / CTOs.
  • Validation Requirements: Experience with assessing validation requirements for laboratory, facilities and equipment.
  • Priority Management: The ability to manage multiple priorities with aggressive timelines and changing priorities.