Novartis
Head Quality Systems and Compliance (Assoc Dir)
Durham
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About the role
- Provide oversight of quality systems including deviations, corrective and preventive actions, exceptions, change controls, data integrity, eCompliance, key performance indicators, and key quality indicators.
- Join Novartis as our QA Compliance and Systems Head and help shape the quality foundation that enables the delivery of medicines to patients worldwide.
- You will oversee Quality Systems, Compliance, Audit and Inspection Readiness, Data Integrity, Supplier Quality, and Validation programs while partnering across Quality, Manufacturing, Engineering, and Regulatory functions.
Responsibilities
- 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 that support sustainable inspection readiness.
- Lead, coach, and develop the QA Compliance and Systems team through effective resource planning, performance management, talent development, training governance, and sustained training compliance.
- Advance digital enablement and continuous improvement initiatives that strengthen quality performance, simplify processes, and support site transformation.
- Demonstrated leadership experience managing teams, developing talent, driving performance, fostering training compliance, and building a culture of accountability and collaboration.
- Lead the site Quality Management System and ensure compliance with Novartis Quality Manual, current Good Manufacturing Practice requirements, and regulatory standards.
Nice to have
- Bachelor of Science or Master of Science in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related scientific discipline
- advanced degree preferred.
- Minimum 8-10 years of experience in pharmaceutical manufacturing, which may include expert roles in Production, Manufacturing Science and Technology, Quality, or Engineering.
- Prior experience in oral solid dose manufacturing preferred.
Skills
- Business Acumen, Collaboration, Data Integrity, Decision Making, Leadership, Risk Management, Strategic Planning
Compensation
- $138,600.00 - $257,400.00
Benefits
- Drive continuous inspection readiness and lead preparation for corporate audits, customer audits, external audits, and Health Authority inspections.
This listing is sourced directly from Novartis's careers page and normalized into a canonical job model.