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Director, Quality Assurance, Upstream Manufacturing

Reference Number: 2791
Location: MA

Our client is a rapidly growing biopharmaceutical company.  They have asked us to assist them in their search for a Director, Quality Assurance, Upstream Manufacturing.

The Director, Quality Assurance, Upstream Manufacturing will be responsible for the establishment of QA Policies and Procedures for multiple Upstream manufacturing sites, batch review and release, and management of Internal Audits to assure that all aspects of manufacturing are executed in compliance with applicable US FDA, ICH GCP Guidelines and other government and/or country specific regulations.  This position will also support continuous improvement of the Quality System and support implementation of technical quality training programs.  The incumbent will develop all local site level quality practices in alignment with overall corporate strategies.

Major tasks and responsibilities will include:

  • Evaluates existing QA policies and procedures and makes changes where applicable.
  • Establishes process for batch review and release in conformance with all regulations.
  • Plans, prepares and performs internal and external system audits as well as study-related audits.
  • Makes audit reports and submission of proposals for solving known problems including follow-up of corrective measures.
  • Develops, maintains and manages quality systems that conform to applicable US and international regulatory requirements.
  • Trains employees on quality management and GCP/GMP.
  • Assists in development of guidelines and standards on an international level.
  • Leads and participates in quality improvement projects.

We seek candidates with the following qualifications:

  • 7-10 years of experience in QA in a clinical development or manufacturing setting.
  • Drug safety and quality management experience, preferably as a Quality Assurance auditor.
  • Extensive knowledge of international authority regulations and of clinical trials.
  • Previous leadership experience.
  • Knowledge of Pharmacovigilance and Good Laboratory Practices.
  • Ability to be productive and successful in an intense work environment.
  • Knowledge and direct experience in the commercial launch of biologic products is preferred.
  • Must demonstrate considerable knowledge in QA and GMP within a commercial Pharmaceutical/Biotech manufacturing setting including the set up and conduct of internal and external GCP/GMP audits.
  • The role will also require a pragmatic approach, good multitasking capabilities, attention to detail and an innovative approach.

 

 

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 2791. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.