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Quality Assurance Manager-GCP

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Title: Quality Assurance Manager-GCP
Position Type: Permanent
Location: Raleigh

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 in search of a confident, highly-respected Quality Assurance professional for one of my most innovative biopharmaceutical clients developing life-changing oncology/hematological and COVID-19 therapies located in RTP.

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

Responsibilities:

  • Lead quality assurance compliance initiative from drug development through commercialization, including the manufacture of clinical products, conduct of clinical trials, oversight of GCP/GMP/GLP CROs, and the manufacture/distribution of commercial products globally
  • Lead GCP/GMP/GLP 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 GXP regulations in the biotechnology or pharmaceutical industry
  • Accomplished GCP/GMP/GLP 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