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- Serve as a thought partner to the GMP Compliance and Inspections leadership, utilizing strong critical thinking skills to address complex problems.
- Lead proactive evaluations of site GMP compliance against current and emerging regulatory trends.
- Define and implement systems and metrics for maintaining regulatory compliance across all operations.
- Evaluate GMP compliance across all areas of the site, including procedures and processes.
- Interface with customer/partner quality organizations and participate on internal committees/teams as required.
- Provide advice and direction to other departments on quality and regulatory issues.
- Benchmark leading practices and recommend improvements to ensure IOPS is inspection-ready at all times.
Director Gmp Compliance - Munster - Regeneron Pharmaceuticals, Inc
1 month ago
Description
Job Title:
DIRECTOR OF GMP COMPLIANCE & INSPECTIONS
About the Role:
This position requires a highly skilled individual to drive activities ensuring continuous Good Manufacturing Practice (GMP) compliance within Regeneron IOPS.
The Director will lead cross-functional teams in building inspection readiness capabilities and educate the organization on compliance awareness.
Key Responsibilities:
Requirements:
A BA/BS degree in Life Sciences or related field, along with 12+ years of relevant experience in the pharmaceutical or biotech industries, or an equivalent combination of education and experience.
Estimated Salary: $170,000 - $200,000 per year.
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