Principal Quality Compliance Specialist, Inspection (CVRM)
About The Position
The Principal Quality Compliance Specialist will serve as the site Inspection Lead at Genentech’s Holly Springs, North Carolina facility, a greenfield drug product manufacturing site planned to launch in 2028. The role oversees the site self-inspection program and owns the strategy for inspection readiness and responses to Health Authority inspections, helping maintain continuous audit readiness and establish a robust, risk-oriented Quality Culture. The Inspection Lead will develop and improve self-inspection and internal audit activities, coordinate targeted assessments and risk assessments, and ensure findings are remediated with appropriate root-cause analysis. The role also prepares subject matter experts and leadership for regulatory interactions, manages Health Authority commitments and post-inspection actions, and supports quality systems and compliance processes. The position works across functions and with global quality and regulatory partners to support continuous improvement and operational excellence.
Requirements
- Bachelor’s degree in a scientific or technical discipline.
- Minimum 8–10 years of experience in a GxP environment.
- At least 3 years leading site or global inspection readiness programs.
- Proven ability to coach, prepare, and align subject matter experts and leadership teams for high-stakes regulatory interactions and manage post-inspection commitments.
- Expertise in global GxP regulations, including FDA, EMA, ICH, and ISO, and their application in digital, sterile manufacturing, and device packaging environments.
- Demonstrated track record of designing, overseeing, and executing a robust site self-inspection program.
- Exceptional cross-functional leadership, communication, and stakeholder management skills, including the ability to influence continuous improvement without formal authority.
- Ability to thrive in dynamic, fast-paced greenfield or start-up environments while upholding rigorous compliance and operational standards.
Nice To Haves
- Advanced degree.
Responsibilities
- Lead, oversee, and continuously improve the site’s self-inspection and internal audit strategy.
- Coordinate targeted deep-dive assessments and complex risk assessments across site operations.
- Ensure timely remediation of self-inspection findings and drive root-cause analysis.
- Develop and execute the site’s inspection readiness strategy to maintain continuous audit readiness.
- Translate global compliance trends and regulatory mandates into actionable site plans and controls.
- Partner cross-functionally to coach and prepare subject matter experts for regulatory interactions.
- Manage Health Authority commitments, inspection responses, and post-inspection action tracking.
- Maintain alignment with global quality and regulatory partners to facilitate Health Authority engagements.
- Support core quality systems to ensure consistent compliance, operational effectiveness, and continuous improvement.
- Support Quality Escalations, Recalls, Inspection Management, Site Master File, Management Reviews, and Supplier Management.
Benefits
- Relocation assistance is available.
- A discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
