Regulatory Operations, GCP Compliance (West Coast)

About Brio

Brio Resource Group is a search firm committed to providing rare talent on an executive search basis to the pharmaceutical, Biopharma and Medical Device industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.

We work with organizations across several industry disciplines, with our strongest portfolio in the Medical Affairs and Drug Development. With US offices located in Washington DC (East Coast) and San Diego (West Coast) we connect rare talent with emerging biopharmaceutical companies nationwide.

Job Description: Regulatory Operations, GCP Compliance

We are partnering with a biopharma with a massive global reach on a confidential search for a leader of Regulatory Operations, GCP Compliance to join their growing Regulatory Affairs division. This role will serve as the leader for the pharmacovigilance audit program, to include internal process audits and external vendor audits, coordinating audit follow-up and corrective action planning.

We welcome the opportunity to provide a full job description upon resume review.

Highlights & Requirements:

  • 8+ years of experience in a relevant environment consisting of working in a pharmaceutical QA, QC or Compliance environment
  • Experience in leading and assisting all types of GCP Audits (system, vendor, IS, CPO, etc.)
  • Good working knowledge of CAPA’s, SOP reviews, Audit Readiness, Audit Strategies, Risk Assessments and Regulatory Inspections
  • Experience in participating and leading GCP/Audit/Inspection readiness training programs
  • CRO or Investigator Audits
  • Understanding of current global and regional trends in regulatory compliance
  • Strong leadership skills
  • Must have excellent verbal, written and interpersonal communication skills

How To Apply:

In order to be considered for the above opportunity, please send a Word version of your resume to the address listed below, and the appropriate member of our executive recruitment team will review your credentials.

Submit Resume to:

We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.

Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.