Novartis
Head,QAOpsandCompliance(AssociateDirectorLevel)
“Head, QA Ops and Compliance (Associate Director Level) at Novartis. Skills: Quality Assurance, Compliance, Operations Leadership, People Management, Regulatory Affairs. 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 pro”
What You'll Achieve.
ensuring excellence in cGMP compliance, regulatory execution, and quality oversight across all operational activities; ensures that all products, manufactured on site, by external partners, or imported, are released to market in full alignment with Novartis Quality Standards, policies, and global regulatory requirements; safeguarding product quality; enabling operational excellence; supporting the reliable and compliant supply of high quality small molecule therapies to patients; adherence to cGMP, regulatory requirements, and internal quality standards; timely root cause analysis; effective CAPA implementation; sustainable corrective actions; inspection readiness for internal, external, and regulatory audits; Drive QA Operational Excellence through performance metrics (KPIs/KQIs); proactive identification of quality and process risks; review and approval of validation strategies and OQ/PQ execution; retain a high-performing QA team
Industry & Context.
Problem Solving Skills; root cause analysis; deviation investigations; OOX/OOS events; complaints; adverse events
This role is on-site 5 days a week and does not have the ability to work remotely., This role is located in Durham, NC and will eventually move to Morrisville, NC at a later date
What They're Looking For.
Must Have
Minimum 10+ years of experience in pharmaceutical, biotechnology, or cell and gene therapy industry within cGMP regulated environments, Demonstrated experience supporting Small Molecule Operations (SMO), including small molecule drug product and/or drug substance environments, Demonstrated hands-on leadership in Quality Operations and Quality Systems & Compliance, with direct responsibility for product release, quality systems, and audit readiness within Small Molecule Operations (SMO), Minimum 6-10 years of direct people leadership, including team development, performance management, and cross-functional collaboration, working knowledge of FDA, EMA, and global regulatory requirements, including experience supporting regulatory inspections and audits, Proven experience leading deviation investigations, CAPA management, and continuous improvement initiatives in an operational QA setting, Experience supporting manufacturing operations, Quality Control, validation, and technology transfer activities, Excellent communication, decision-making, and organizational skills, with the ability to operate effectively in a fast-paced CGT manufacturing environment, Fluency in English (written and verbal)
Nice to Have
BS or MS in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related scientific advanced degree
What You'll Do.
Provide end-to-end leadership for Quality Operations and Compliance across manufacturing
ensuring adherence to cGMP
regulatory requirements
and internal quality standards
Serve as the final QA authority for review
and release of batch documentation and patient or commercial product lots manufactured at the site
Ensure on-the-floor QA presence
delivering real-time quality oversight
and guidance to support compliant and efficient operations
Lead investigations of deviations
ensuring timely root cause analysis
effective CAPA implementation
and sustainable corrective actions
Implement and maintain site Quality Systems
including SOP governance
documentation control
and inspection readiness for internal
and regulatory audits
Drive QA Operational Excellence through performance metrics (KPIs/KQIs)
continuous improvement initiatives
and proactive identification of quality and process risks
Provide QA leadership for technology transfers
and new equipment commissioning
including review and approval of validation strategies and OQ/PQ execution
and retain a high-performing QA team through hiring
performance management
and resource planning
while supporting budget and capacity planning in alignment with site strategy
How You'll Work.
Team & Collaboration
partners closely with manufacturing and external suppliers; cross-functional collaboration
Communication Scope
Excellent communication skills
Process & Methodology
technology transfers, process validation, new equipment commissioning
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