Director GCP QA

Prestige Scientific - 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

 

COMPETENCIES

 

  • 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.

 

WHAT’S NEXT?

I’ve included a link to short, 90-second video to provide some highlights of this leadership opportunity.

https://www.loom.com/share/e2a6180321f2444ea345e7217a53c1f1

 

Want to learn more? Give us a call!

 

Mark Carlson, CPC
Director – Quality Assurance

(857) 202-3238
mcarlson@prestigescientific.com

 

#gcp_qa #cqa #clinical_quality #r&d_qa #gcp

 



Posted On: Tuesday, August 25, 2020
Compensation: $205,000.00



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