Director GCP QA
- S San Francisco, CA
ABOUT THE COMPANY
Our client is a biopharmaceutical company with a current commercial success and an incredibly strong portfolio of programs soon to follow. With extremely positive data in 2 programs, they're gearing up to file BLAs for both programs.
THE ROLE YOU WILL PLAY:
Due to the growth of the organization, they need a GCP expert who can plan and run audits internally and with their vendors. This role will be the lead on GCP related inspections. In this role, you will:
- Demonstrate your expertise in designing and implementing clinical standards and procedures that meet or exceed ICH/GCP guidelines and regulations
- Show top leadership why you are a recognized expert in developing oversight programs of audits and building audit strategies to insure GCP, GLP, and GVP compliance and inspection readiness
- Stand out above your peers by being able to ensure successful implementation of audit plans and functioning as the “internal expert” on all things related to GCP compliance
- Hands-on experience in GCP Quality for the US and EU. Other parts of the world would be awesome!
- A track record of planning and running audits, internally and externally
- An advisory approach to help other departments and teams
- Advanced knowledge in the conduct and reporting of Heath Authority inspections and the translation of findings into corrective action.
- Strong verbal and written communication
- Ability to travel
WHAT'S IN IT FOR YOU:
- Unfettered growth potential
- An opportunity to work with the senior leadership of an organization and be an influencer
- An unparalleled compensation program and an extremely rich benefits plan
This client offers exceptional compensation including base, bonus, stock options, and an excellent benefits package.
I’ve included a link to short, 90-second video to provide some highlights of this leadership opportunity.
Want to learn more? Give us a call!
Mark Carlson, CPC
Director – Quality Assurance
#gcp_qa #cqa #clinical_quality #r&d_qa #gcp
Tuesday, August 25, 2020