Head, QA Ops and Compliance (Associate Director Level)
Novartis
June 30, 2026
On-site
Durham, NC
Operations
Location: Durham, NC (on-site 5 days/week; no remote). Will eventually move to Morrisville, NC.
Key Responsibilities
- Provide end-to-end leadership for Quality Operations and Compliance across manufacturing, Quality Control, AS&T, and logistics to ensure cGMP, regulatory, and internal quality adherence.
- Serve as final QA authority for review, approval, and release of batch documentation and patient/commercial lots.
- Maintain strong on-the-floor QA presence for real-time oversight, decision-making, and guidance.
- Lead investigations for deviations, OOX/OOS events, complaints, and adverse events; ensure timely root cause analysis and CAPA implementation.
- Implement and maintain site Quality Systems (SOP governance, training compliance, documentation control, and audit readiness).
- Drive QA Operational Excellence via KPIs/KQIs, continuous improvement, and risk identification.
- Provide QA leadership for technology transfers, process validation, and new equipment commissioning (review/approval of validation strategies; OQ/PQ execution).
- Lead, develop, and retain the QA team (hiring, coaching, performance management, resource/budget and capacity planning).
Essential Requirements
- BS or MS in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field (advanced degree preferred).
- 10+ years in cGMP-regulated pharma/biotech (cell and gene therapy experience acceptable).
- Demonstrated experience with Small Molecule Operations (drug product and/or drug substance).
- Hands-on leadership in Quality Operations/Systems & Compliance, including product release and audit readiness.
- 6–10 years people leadership; cross-functional collaboration.
- Strong FDA/EMA/global regulatory knowledge; inspection/audit experience.
- Proven deviation investigation, CAPA, and continuous improvement experience.
- Experience supporting manufacturing, Quality Control, validation, and technology transfer.
- Excellent communication/decision-making/organizational skills; fluency in English.
Compensation and Benefits (as stated)
- Salary range: $138,600–$257,400/year; performance cash incentive; possible annual equity.
- Comprehensive US benefits and generous time off (vacation, personal days, holidays, and leaves).
Key Responsibilities
- Provide end-to-end leadership for Quality Operations and Compliance across manufacturing, Quality Control, AS&T, and logistics to ensure cGMP, regulatory, and internal quality adherence.
- Serve as final QA authority for review, approval, and release of batch documentation and patient/commercial lots.
- Maintain strong on-the-floor QA presence for real-time oversight, decision-making, and guidance.
- Lead investigations for deviations, OOX/OOS events, complaints, and adverse events; ensure timely root cause analysis and CAPA implementation.
- Implement and maintain site Quality Systems (SOP governance, training compliance, documentation control, and audit readiness).
- Drive QA Operational Excellence via KPIs/KQIs, continuous improvement, and risk identification.
- Provide QA leadership for technology transfers, process validation, and new equipment commissioning (review/approval of validation strategies; OQ/PQ execution).
- Lead, develop, and retain the QA team (hiring, coaching, performance management, resource/budget and capacity planning).
Essential Requirements
- BS or MS in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field (advanced degree preferred).
- 10+ years in cGMP-regulated pharma/biotech (cell and gene therapy experience acceptable).
- Demonstrated experience with Small Molecule Operations (drug product and/or drug substance).
- Hands-on leadership in Quality Operations/Systems & Compliance, including product release and audit readiness.
- 6–10 years people leadership; cross-functional collaboration.
- Strong FDA/EMA/global regulatory knowledge; inspection/audit experience.
- Proven deviation investigation, CAPA, and continuous improvement experience.
- Experience supporting manufacturing, Quality Control, validation, and technology transfer.
- Excellent communication/decision-making/organizational skills; fluency in English.
Compensation and Benefits (as stated)
- Salary range: $138,600–$257,400/year; performance cash incentive; possible annual equity.
- Comprehensive US benefits and generous time off (vacation, personal days, holidays, and leaves).