GMP Validation & Regulatory Expert - API Manufacturing
Job in
Cleveland, Cuyahoga County, Ohio, 44101, USA
Listed on 2026-08-22
Listing for:
Skills Alliance Enterprise
Full Time
position Listed on 2026-08-22
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Pharmaceutical
Pharmaceutical Manufacturing, Regulatory Compliance Specialist
Job Description & How to Apply Below
Skills Alliance Enterprise in the United States is seeking a senior professional to lead GMP regulatory and validation activities for API manufacturing. You will guide compliance, validation strategy, and documentation, coordinating with QA, Manufacturing, Regulatory Affairs, IT, and Technical Operations to ensure inspections readiness.
Ideal candidates have 8–15+ years in pharma/biotech, deep ICH Q7 knowledge, and proven audit experience.
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