Principal Quality Compliance Specialist, Inspection (CVRM)

The Opportunity

We seek a highly impactful Principal Quality Compliance Specialist who will serve as the site Inspection Lead. In this critical role, you will oversee the execution of the site self-inspection program and fully own the site's inspection readiness and response strategy for Health Authority inspections. As the site Inspection Lead, you will serve as the foundational compliance anchor and will play a vital role to maintain a continuous state of audit readiness.

This position is a unique opportunity to embed a robust, risk-oriented Quality Culture into the site's operational design, lead Health Authority engagement, support continuous improvement, and drive operational excellence, establishing Holly Springs as a center of excellence for aseptic drug product manufacturing.

What You'll Do

• 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 identified self-inspection findings and drive root-cause analysis.
• Develop and execute the site's inspection readiness strategy to ensure continuous state of 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 seamless health authority engagements.
• Provide support to core quality systems to ensure consistent compliance, operational effectiveness, and continuous improvement.
• Support key compliance processes, including Quality Escalations, Recalls, Inspection Management, Site Master File, Management Reviews, and Supplier Management.

Who You Are

• Bachelor's degree in a scientific/technical discipline (Advanced degree preferred).
• Minimum 8–10 years in a GxP environment, with at least 3 years leading site or global inspection readiness programs.
• Proven ability to coach, prepare, and align subject matter experts (SMEs) and leadership teams for high-stakes regulatory interactions, and managing post-inspection commitments.
• Expertise in global GxP regulations (FDA, EMA, ICH, ISO) and their application in digital, sterile manufacturing and device packaging environments.
• Demonstrated track record of designing, overseeing, and executing robust site self-inspection program.
• Exceptional cross-functional leadership, communication, and stakeholder management skills to influence continuous improvement without formal authority.
• Thrives in dynamic, fast-paced greenfield or start-up environments while upholding rigorous compliance and operational standards.