Principal Quality Compliance Specialist, Inspection (CVRM)
About The Position
The Principal Quality Compliance Specialist will serve as the site Inspection Lead at Genentech’s new Holly Springs, North Carolina drug product manufacturing facility. The role owns the site’s inspection readiness and response strategy for Health Authority inspections and oversees the execution and ongoing improvement of the site self-inspection program. The position helps establish a risk-oriented Quality Culture and maintain continuous audit readiness while supporting continuous improvement and operational excellence. The facility is a greenfield start-up focused on high-volume drug product manufacturing, including CVRM (Cardiovascular, Renal, and Metabolism) medicines. It uses advanced automation, robotics, digital tools, real-time data analytics, and streamlined processes, with a planned launch in 2028. The Inspection Lead will work cross-functionally to prepare subject matter experts and leadership for regulatory interactions, manage inspection commitments and responses, and support core quality systems and compliance processes.
Requirements
- Bachelor’s degree in a scientific or technical discipline.
- Minimum 8–10 years of experience in a GxP environment, including 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 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
