Head Quality Systems and Compliance (Assoc Dir)
Novartis
September 03, 2026
On-site
Durham, NC
Operations
Key Responsibilities:
- Lead the site Quality Management System to ensure compliance with Novartis Quality Manual, current cGMP requirements, and regulatory standards.
- Drive continuous inspection readiness and lead preparation for corporate, customer, external, and Health Authority inspections.
- Oversee quality systems: deviations, CAPA, exceptions, change controls, data integrity, eCompliance, KPIs, and quality indicators.
- Partner with Manufacturing, Quality Control, Validation, Technical Operations, Engineering, and Regulatory to support site operations, technology transfers, qualifications, and validation.
- Lead investigations of deviations, out-of-expectation events, complaints, and compliance issues to ensure timely, effective resolution.
- Oversee supplier quality, regulatory compliance, training governance, and risk management.
- Lead, coach, and develop the QA Compliance and Systems team (resource planning, performance management, talent development, training governance).
- Promote a quality culture focused on accountability, collaboration, continuous improvement, employee development, and proactive risk management.
- Advance digital enablement and continuous improvement initiatives to strengthen quality performance and support site transformation.
Essential Requirements:
- BS or MS in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field; advanced degree preferred.
- 8–10+ years in pharmaceutical manufacturing (Production, MSAT, Quality, or Engineering); oral solid dose experience preferred.
- Demonstrated leadership managing teams, developing talent, driving performance, and fostering training compliance/accountability.
- Significant experience leading FDA inspections, regulatory interactions, audit readiness, and inspection remediation.
- Strong Quality Systems expertise (deviations, CAPA, change control, data integrity, validation, compliance oversight).
- Proven ability to lead risk management, continuous improvement, and compliance in highly regulated environments.
Desirable Requirements:
- Experience with facility start-ups, qualifications, validations, transfers.
- Lean/Operational Excellence or comparable continuous improvement certification.
Application instructions (accessibility): If a reasonable accommodation is needed, email [email protected] or call +1(877)395-2339 and include the job requisition number.
- Lead the site Quality Management System to ensure compliance with Novartis Quality Manual, current cGMP requirements, and regulatory standards.
- Drive continuous inspection readiness and lead preparation for corporate, customer, external, and Health Authority inspections.
- Oversee quality systems: deviations, CAPA, exceptions, change controls, data integrity, eCompliance, KPIs, and quality indicators.
- Partner with Manufacturing, Quality Control, Validation, Technical Operations, Engineering, and Regulatory to support site operations, technology transfers, qualifications, and validation.
- Lead investigations of deviations, out-of-expectation events, complaints, and compliance issues to ensure timely, effective resolution.
- Oversee supplier quality, regulatory compliance, training governance, and risk management.
- Lead, coach, and develop the QA Compliance and Systems team (resource planning, performance management, talent development, training governance).
- Promote a quality culture focused on accountability, collaboration, continuous improvement, employee development, and proactive risk management.
- Advance digital enablement and continuous improvement initiatives to strengthen quality performance and support site transformation.
Essential Requirements:
- BS or MS in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field; advanced degree preferred.
- 8–10+ years in pharmaceutical manufacturing (Production, MSAT, Quality, or Engineering); oral solid dose experience preferred.
- Demonstrated leadership managing teams, developing talent, driving performance, and fostering training compliance/accountability.
- Significant experience leading FDA inspections, regulatory interactions, audit readiness, and inspection remediation.
- Strong Quality Systems expertise (deviations, CAPA, change control, data integrity, validation, compliance oversight).
- Proven ability to lead risk management, continuous improvement, and compliance in highly regulated environments.
Desirable Requirements:
- Experience with facility start-ups, qualifications, validations, transfers.
- Lean/Operational Excellence or comparable continuous improvement certification.
Application instructions (accessibility): If a reasonable accommodation is needed, email [email protected] or call +1(877)395-2339 and include the job requisition number.