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Manager/Director, Clinical Quality Assurance

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Title: Manager/Director, Clinical Quality Assurance
Position Type: Permanent
Location: Raleigh/ Durham, NC

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

Our client is seeking a confident, highly-respected Quality Assurance Leader with one of my most innovative biopharmaceutical clients developing life-changing immuno-oncology therapies located in RTP.

Responsibilities:

  • Lead quality assurance oversight of quality, compliance, and auditing activities to ensure compliance with corporate policies, industry standards, and applicable regulations and guidelines.
  • Lead GCP QA oversight for research & development (R&D) activities required at all stages of oncology products' life cycle.
  • Establish, maintain and improve quality systems, training and document control systems, internal and external audits deviations and CAPAs
  • Support audit activities and regulatory agencies (FDA, EMA), and state board health inspections

Requirements:

  • Minimum of 6-10+ years of progressive experience in the areas of GCP regulations in the biotechnology, pharmaceutical industry or CRO company
  • Accomplished GCP Auditing and Compliance background
  • Willingness to be part of an emerging development-stage company with tremendous growth potential

How To Apply:

Please submit your CV to CV@briogrp.com or click “APPLY. An appropriate member of our executive recruitment team will review your credentials and respond to arrange an initial interview to review your credentials and career objectives.

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