Head Quality Systems and Compliance (Assoc Dir)
Novartis
August 13, 2026
On-site
Durham, NC
Operations
Key Responsibilities
- Lead the site Quality Management System and ensure compliance with Novartis Quality Manual, current Good Manufacturing Practice requirements, and regulatory standards.
- Drive continuous inspection readiness and lead preparation for corporate audits, customer audits, external audits, and Health Authority inspections.
- Oversee quality systems including deviations, corrective and preventive actions, exceptions, change controls, data integrity, eCompliance, key performance indicators, and key quality indicators.
- Partner with Manufacturing, Quality Control, Validation, Technical Operations, Engineering, and Regulatory teams to support site operations, technology transfers, qualifications, and validation activities.
- Lead investigations of deviations, out-of-expectation events, complaints, and compliance issues, ensuring timely and effective resolution.
- Oversee supplier quality, regulatory compliance, training governance, and risk management programs.
- Lead, coach, and develop the QA Compliance and Systems team (resource planning, performance management, talent development, training governance, training compliance).
- Promote a strong quality culture and proactive risk management.
- Advance digital enablement and continuous improvement initiatives.
Essential Requirements
- BS/MS in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related discipline; advanced degree preferred.
- 8–10+ years in pharmaceutical manufacturing (Production, MS&T, Quality, or Engineering); oral solid dose experience preferred.
- Leadership experience managing teams, developing talent, driving performance, fostering training compliance.
- Significant experience leading FDA inspections, regulatory interactions, audit readiness, and remediation.
- Strong Quality Systems experience (deviations, CAPA, change control, data integrity, validation, compliance oversight).
- Proven ability to lead risk management and continuous improvement in regulated environments.
Desirable Requirements
- Experience with facility start-ups, qualifications, validations, transfers.
- Lean Management/Operational Excellence or comparable continuous improvement certification/methodologies.
Application Instructions
- Apply with your request including the job requisition number (for accommodations: e-mail [email protected] or call +1(877)395-2339).
- Lead the site Quality Management System and ensure compliance with Novartis Quality Manual, current Good Manufacturing Practice requirements, and regulatory standards.
- Drive continuous inspection readiness and lead preparation for corporate audits, customer audits, external audits, and Health Authority inspections.
- Oversee quality systems including deviations, corrective and preventive actions, exceptions, change controls, data integrity, eCompliance, key performance indicators, and key quality indicators.
- Partner with Manufacturing, Quality Control, Validation, Technical Operations, Engineering, and Regulatory teams to support site operations, technology transfers, qualifications, and validation activities.
- Lead investigations of deviations, out-of-expectation events, complaints, and compliance issues, ensuring timely and effective resolution.
- Oversee supplier quality, regulatory compliance, training governance, and risk management programs.
- Lead, coach, and develop the QA Compliance and Systems team (resource planning, performance management, talent development, training governance, training compliance).
- Promote a strong quality culture and proactive risk management.
- Advance digital enablement and continuous improvement initiatives.
Essential Requirements
- BS/MS in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related discipline; advanced degree preferred.
- 8–10+ years in pharmaceutical manufacturing (Production, MS&T, Quality, or Engineering); oral solid dose experience preferred.
- Leadership experience managing teams, developing talent, driving performance, fostering training compliance.
- Significant experience leading FDA inspections, regulatory interactions, audit readiness, and remediation.
- Strong Quality Systems experience (deviations, CAPA, change control, data integrity, validation, compliance oversight).
- Proven ability to lead risk management and continuous improvement in regulated environments.
Desirable Requirements
- Experience with facility start-ups, qualifications, validations, transfers.
- Lean Management/Operational Excellence or comparable continuous improvement certification/methodologies.
Application Instructions
- Apply with your request including the job requisition number (for accommodations: e-mail [email protected] or call +1(877)395-2339).