Head, QA Ops and Compliance

Job Description Summary

Job Description

#LI-Onsite

Location: Durham NC

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

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 including SOP governance training compliance documentation control and inspection readiness for internal external 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 process validation and new equipment commissioning including review and approval of validation strategies and OQ/PQ execution.

• Lead develop and retain a high-performing QA team through hiring coaching performance management and resource planning while supporting budget and capacity planning in alignment with site strategy.

Essential Requirements:

• BS or MS in Life Sciences Pharmacy Chemistry Biotechnology or related scientific discipline; advanced degree preferred.

• Minimum 10 years of experience in pharmaceutical biotechnology or cell and gene therapy industry within cGMP regulated environments.

• Demonstrated experience in Quality Operations and/or Quality Systems & Compliance leadership roles with direct responsibility for product release quality systems and audit readiness.

• Minimum 6-10 years of direct people leadership including team development performance management and cross-functional collaboration.

• Strong 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).

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $138600 and $257400/year. The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity -based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired