Head, QA Ops and Compliance
Novartis
3 months ago
On-site
Durham, NC
$138,600 - $257,400 USD yearly
Operations
Key Responsibilities:
- Provide end-to-end leadership for Quality Operations and Compliance across manufacturing, Quality Control, AS&T, and logistics, ensuring adherence to cGMP, regulatory requirements, and internal quality standards.
- Serve as the final QA authority for review, approval, and release of batch documentation and patient or commercial product lots manufactured at the site.
- Ensure strong on-the-floor QA presence, delivering real-time quality oversight, decision-making, and guidance to support compliant and efficient operations.
- Lead investigations of deviations, OOX/OOS events, complaints, and adverse events, ensuring timely root cause analysis, effective CAPA implementation, and sustainable corrective actions.
- Implement and maintain site Quality Systems (SOP governance, training compliance, documentation control, and inspection readiness).
- Drive QA Operational Excellence through KPIs/KQIs, continuous improvement, and proactive identification of quality/process risks.
- Provide QA leadership for technology transfers, process validation, and new equipment commissioning (review/approval of validation strategies; OQ/PQ execution).
- Lead, develop, and retain a high-performing QA team (hiring, coaching, performance management, resource and capacity planning).
Essential Requirements:
- BS or MS in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related discipline; advanced degree preferred.
- 10+ years’ experience in cGMP-regulated pharmaceutical/biotech (or cell/gene therapy) environments.
- Demonstrated experience supporting Small Molecule Operations (SMO), including drug product and/or drug substance.
- Hands-on leadership in Quality Operations and Quality Systems & Compliance with responsibility for product release, quality systems, and audit readiness (SMO).
- 6–10 years of direct people leadership.
- Strong knowledge of FDA, EMA, and global regulatory requirements; experience with regulatory inspections/audits.
- Proven experience leading deviation investigations, CAPA management, and continuous improvement.
- Experience supporting manufacturing operations, Quality Control, validation, and technology transfer.
- Excellent communication, decision-making, and organizational skills.
- Fluency in English (written and verbal).
Benefits:
- Expected salary range: $138,600–$257,400/year; performance-based cash incentive; eligibility for annual equity awards (role-dependent).
- US-based eligible employees receive a comprehensive benefits package including health, life and disability, and a 401(k) with company contribution and match; time off including vacation, personal days, holidays, and other leaves.
Location/Work Setting:
- On-site 5 days/week; no remote work. Durham, NC (later move to Morrisville, NC).
- Provide end-to-end leadership for Quality Operations and Compliance across manufacturing, Quality Control, AS&T, and logistics, ensuring adherence to cGMP, regulatory requirements, and internal quality standards.
- Serve as the final QA authority for review, approval, and release of batch documentation and patient or commercial product lots manufactured at the site.
- Ensure strong on-the-floor QA presence, delivering real-time quality oversight, decision-making, and guidance to support compliant and efficient operations.
- Lead investigations of deviations, OOX/OOS events, complaints, and adverse events, ensuring timely root cause analysis, effective CAPA implementation, and sustainable corrective actions.
- Implement and maintain site Quality Systems (SOP governance, training compliance, documentation control, and inspection readiness).
- Drive QA Operational Excellence through KPIs/KQIs, continuous improvement, and proactive identification of quality/process risks.
- Provide QA leadership for technology transfers, process validation, and new equipment commissioning (review/approval of validation strategies; OQ/PQ execution).
- Lead, develop, and retain a high-performing QA team (hiring, coaching, performance management, resource and capacity planning).
Essential Requirements:
- BS or MS in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related discipline; advanced degree preferred.
- 10+ years’ experience in cGMP-regulated pharmaceutical/biotech (or cell/gene therapy) environments.
- Demonstrated experience supporting Small Molecule Operations (SMO), including drug product and/or drug substance.
- Hands-on leadership in Quality Operations and Quality Systems & Compliance with responsibility for product release, quality systems, and audit readiness (SMO).
- 6–10 years of direct people leadership.
- Strong knowledge of FDA, EMA, and global regulatory requirements; experience with regulatory inspections/audits.
- Proven experience leading deviation investigations, CAPA management, and continuous improvement.
- Experience supporting manufacturing operations, Quality Control, validation, and technology transfer.
- Excellent communication, decision-making, and organizational skills.
- Fluency in English (written and verbal).
Benefits:
- Expected salary range: $138,600–$257,400/year; performance-based cash incentive; eligibility for annual equity awards (role-dependent).
- US-based eligible employees receive a comprehensive benefits package including health, life and disability, and a 401(k) with company contribution and match; time off including vacation, personal days, holidays, and other leaves.
Location/Work Setting:
- On-site 5 days/week; no remote work. Durham, NC (later move to Morrisville, NC).