An independent contributer for a pharmaceutical company, acting to ensure that Quality Compliance concerns are appropriately evaluated, investigated, and resolved. Oversee cGMP audits and ensures that all sites are continually in a state of cGMP inspection readiness.
- Oversee cGMP inspection readiness by ensuring cGMP compliance to regulatory requirements
- Create and review quality compliance policies, guidelines, and systems to ensure quality products, processes, and procedures
- Plan internal regulatory, customer, and vendor audits and make sure all audit observations are appropriately addressed
- 12 or more years of experience in a compliance and auditing role within a cGMP environment
- Strong knowledge of GLP and GMP audits, domestic and international regulatory requirements
- Effective and professional interpersonal skills, previous leadership experience, and strong communication skills