Vice President, Global Quality Compliance
Description
Our client is a large, diverse global pharmaceutical company that is seeking a senior Quality Compliance leader to provide enterprise-wide regulatory compliance oversight across a complex international manufacturing network. This role will serve as the central authority on global GMP compliance strategy and inspection readiness, ensuring sustainable quality systems and regulatory alignment across regions.
The successful candidate will operate at a highly strategic level, interfacing directly with global health authorities while driving continuous compliance improvement across multiple sites and markets.
Location
Remote-based within the United States (Central or Eastern time zones)
Responsibilities
- Provide enterprise-level oversight and subject matter expertise to ensure adherence to applicable global quality and GMP regulations.
- Evaluate and trend global compliance metrics to identify systemic risks and opportunities for improvement.
- Serve as the primary regulatory compliance contact for major global health authorities in matters related to internal manufacturing and packaging operations.
- Lead regulatory interactions and manage health authority communications when required.
- Oversee inspection readiness strategy across a global network of manufacturing facilities.
- Direct preparation and coordination of responses to inspection observations, ensuring thorough root cause analysis and sustainable remediation.
- Monitor and track regulatory commitments to ensure timely and effective completion.
- Oversee the global quality training framework, including governance of enterprise training systems and compliance learning programs.
- Guide implementation of consistent quality practices across regions in alignment with international regulatory expectations.
- Strengthen quality culture and reinforce accountability to maintain continuous inspection readiness.
- Maintain and evolve a regulatory intelligence framework to proactively interpret and communicate emerging regulatory trends.
- Ensure ongoing awareness of evolving regulatory standards and enforcement expectations globally.
Qualifications / Requirements
- 10+ years of leadership experience in global GMP compliance within a multinational pharmaceutical environment.
- Direct experience managing high-stakes regulatory inspections and health authority negotiations (e.g., FDA, EMA, and other major agencies).
- Demonstrated success leading enterprise-wide compliance programs across diverse geographic regions.
- Strong executive presence with the ability to influence site leadership and cross-functional stakeholders.
- Proven capability in developing sustainable quality systems and driving cultural transformation.
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