Title: Senior Manager of GCP
Location: Greater Fremont Area, CA
Salary: Based on Experience + Benefits
Company Summary:
An innovative, cutting edge biopharmaceutical company that focuses on developing combination products in the San Francisco Area. It is a great opportunity to work with exciting new technology and build upon your engineering experience. The right candidate will have experience of having worked in the biopharmaceutical industry and strong understanding of GCP.
Device Engineer Responsibilities:
Provide support to the Quality team by overseeing clinical operations. (QA auditing and GCP activities)
Qualifications:
- BA/MS in relevant field with at least 10 years direct experience with Clinical Development.
- 6+ years of Biotech or Pharma Clinical Quality Audit role or quality auditing experience
- Pharmacovigilance auditing experience is a plus
- Strong familiarity with GCP and GLP requirements and guidelines
- Strong auditing experience with a great understand of guidelines and regulations surrounding Quality and Clinical.
- Experience with interacting, managing and auditing third parties vendors
- Experience in GCP compliant quality systems and processes and working knowledge of FDA regulations is a must.
Benefits/perks:
- Health Benefits (Dental, Vision, Medical)
- 401k
