Compliance Specialist Jobs

About The Position

Requirements

• Bachelor's degree in a scientific or technical discipline.
• At least 8 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 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 a dynamic, fast-paced greenfield or start-up environment 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, the Site Master File, Management Reviews, and Supplier Management.
• Help embed a robust, risk-oriented Quality Culture into the site's operational design and support continuous improvement and operational excellence.

Benefits

• Relocation assistance is available.
• A discretionary annual bonus may be available based on individual and Company performance.