Director GCP QA

Prestige Scientific - San Francisco, CA

ABOUT THE COMPANY

Our client is a biopharmaceutical company focused on realizing the full value of promising drug candidates targeting rare and orphan diseases in the autoimmune and oncology spaces.

On the verge of their first commercial success and an incredibly strong development pipeline, this organization is poised for explosive growth.

 

THE ROLE YOU WILL PLAY

The Director of Clinical Quality Assurance will serve as a subject matter expert to ensure that all quality and regulatory compliance related to GLP/GCP, pharmacovigilance, and other related activities performed by Medical/Clinical Departments.  This critical position will provide support and promote collaboration to ensure all systems, processes and their outcomes are compliant with GLP/GCP guidelines, and applicable international and national standards, regulations and guidelines 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 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

 

  • 7+ years of experience in the pharmaceutical industry, including 4+ years in GCP Quality.
  • Advanced knowledge and demonstrated experience in the applicable GCP/GLP regulations, including ICH Guidelines, including E6 R(2)
  • In-depth knowledge of drug development processes and GCP regulations across all phases.
  • Advanced knowledge in the conduct and reporting of Heath Authority inspections and the translation of findings into corrective action.
  • Strong verbal and written communication

 

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.

This client will offer relocation for the right candidate. Want to learn more? Give us a call!

 

Mark Carlson, CPC
Director – Quality Assurance

(858) 202-3238
mcarlson@prestigescientific.com

 

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



Posted On: Sunday, July 19, 2020
Compensation: $170k - $205k



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