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Vice President of Quality

Reference Number: 2769
Location: MA

Our client is a rapidly growing biopharmaceutical company.  They have asked us to assist them in their search for a Vice President of Quality.

The Vice President of Quality reports to the SVP of Technical Operations.  This individual’s primary responsibility will be to develop and administer our client’s clinical and commercial quality strategy, global quality system, SOPs and training to ensure organizational compliance with regulatory requirements.  The incumbent will have overall responsibility to assure initiatives related to quality and compliance are optimized and executed appropriately.

Major tasks and responsibilities will include:

  • Defines and drives the Quality vision and mindset of the entire company in close collaboration with the executive leadership team.
  • Defines clear Quality objectives and ensures progress and cross-functional completion of responsibilities; uses judgment to develop solutions, and drives risk analysis and mitigation strategies.
  • Ensures appropriate quality assurance and control systems are in place to support product release in a compliant and timely manner, and routinely monitors performance to established targets.
  • Ensures appropriate systems are in place for follow up and closing investigations and audit observations.
  • Ensures that exceptions are analyzed for corrective preventive actions and product impact.
  • Provides technical expertise for product quality decisions and oversees the quality control testing program.
  • Oversees the development, maintenance and management of quality systems that conform to applicable US and international regulatory requirements.
  • Evaluates facility, procedures, equipment, personnel and processes to ensure that they consistently deliver product that meets all applicable requirements.
  • Oversees all aspects of Quality related to the manufacture of biologics.
  • Oversees all quality aspects of the clinical quality assurance programs and GCP management.
  • Provides leadership, guidance, and direction to staff consistent with cGMP including both quality assurance and quality control groups.
  • Interacts with manufacturing, clinical, operations and other functional management as they impact the quality operation.
  • Evaluates and signs off on compliance documentation including approving regulatory filings for designated products.
  • Uses considerable analytical and judgment skills to drive continuous improvements.

We seek candidates with the following qualifications:

  • Bachelors or Advanced degree in a scientific discipline.
  • 15+ years of experience in the pharmaceutical/biotech industry (with drug substance/drug product manufacture, development, analytical, quality, clinical, and/or regulatory).
  • 10+ years of Quality leadership experience, with a successful track record.
  • Experience in biologics manufacturing and analytical development preferred.
  • Experience in the approval and launch of biological products supporting a variety of worldwide markets.
  • Aseptic processing experience preferred.
  • Understanding of worldwide requirements of cGMP and quality systems for commercial and clinical products.
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions.
  • Ability to work successfully with contract manufacturing and research organizations.
  • Experience interacting with regulatory health authorities at pre- and post-approval inspections.
  • Ability to contribute to quality and compliance decisions or to seek expert advice if necessary on a wide area of topics.
  • Commitment to operational excellence.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2769. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.