Reports To: Vice President, Regulatory and Quality
- Regularly applies basic knowledge of both Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) and regulations to independently address a variety of compliance issues associated with drug development
- Maintains Standard Operating Procedures (SOPs)
- Creates and oversees internal quality training and documentation
- Performs assigned audits which may include internal quality assurance unit audits, internal GCP system audits, external GLP and GCP vendor audits and clinical investigator site audits; reviews documents to be submitted to regulatory authorities. During audits, determines compliance status and identifies compliance risks.
- Creates and maintains quality files and documentation
- Bachelor’s degree
- 8 years industry experience and a minimum of 4 years of compliance-related experience
- Knowledge of computer validation and 21 CFR Part 11 and/or Good Manufacturing Practices (GMP) regulations a plus
- Travel required (30%)
Human Resources
Medivation, Inc.
201 Spear Street
3rd Floor
San Francisco, CA 94105
hr@medivation.com
