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Director of Quality Assurance

Reference Number: 2790
Location: MA

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

The Director of Quality Assurance will ensure that an effective Corporate Quality function is established and managed so that the Quality of the company’s products is maintained, the patient’s interests are protected, and the company’s Quality objectives are met.   This position ensures that quality systems are developed and maintained to guarantee compliance with regulations including inspection readiness at all times.

Major tasks and responsibilities will include:

  • Responsible for commercial/clinical lot release; review of validation documentation; change control; deviation/CAPA management; regulatory audit responsibility; quality matrix management; and QA signature approval authority.
  • Ensures that appropriate Quality policies are applied to the products and to the site’s Manufacturing and Contract Operations in accordance with regulatory requirements.
  • Establishes quality objectives and KPIs for the company and ensure these objectives are met and that continuous improvement is demonstrated.
  • Ensures the disposition of Finished Products, APIs, Raw Materials and Components.
  • Ensures the efficient operation of the company’s quality management systems.
  • Promotes a culture of total quality and operational excellence.
  • Promotes continuous improvement, including sponsorship of programs such as Lean Six Sigma.
  • Ensures the effectiveness of the GxP training program for site staff.
  • Ensures an effective Management Review process is in place.
  • Recruits, motivates, leads, and develops the Quality Assurance team.
  • Ensures Quality operations are managed in a cost effective manner in line with the approved budget.
  • Keeps abreast of industry developments – new technology, forthcoming regulations, competitor activity, etc.
  • Enhances the reputation of the company via site excellence and on-going maintenance of external regulatory body relationships.
  • Leads the inspection process to ensure conformity with regulatory authorities.
  • Assures that all products are released in compliance with company procedures.
  • Directs the establishment of QA policies, systems, and procedures to assure compliance with domestic and international GMP regulations.
  • Assures that contract manufacturer organizations are in compliance with appropriate Quality practices to meet the desired quality attributes of the company and to ensure the facilities/Quality Systems pass regulatory inspections.
  • Provides support for the licensing (CTD/NDA/BLA or IND) approval of new products.
  • Oversees the Change Control system.
  • Oversees deviation/CAPA disposition.

We seek candidates with the following qualifications:

  • BS required, MS/PhD preferred in Biological Sciences, Chemistry or Pharmaceutical Engineering.
  • Good knowledge of GxP regulations is a pre-requisite requirement for this position.
  • 10 years of industry experience in a site producing pharmaceutical products under EU and US standards including 5 years of quality management experience.
  • Direct experience in the approval/licensure and launch of a biological product is preferred.

 

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 2790. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.