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VP, Regulatory Affairs & Quality
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Full-time
- The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
- Builds the company's quality system; formulates the company's GMP, GLP and GCP compliance strategies and provide advice and support for all clinical development programs.
- Oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
- Oversees the QA reviews of GMP manufacturing batch records, product release and stability testing, validation reports, pharmacology and toxicology study reports and essential clinical study documents.
- Assess all GMP, GLP and GCP compliance risks to the clinical development programs and develop and implement risk mitigation measures.
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