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Associate Director / Director / Senior Director of Clinical Quality Assurance

Reference Number: 2792
Location: MA

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

The Associate Director / Director / Senior Director of Clinical Quality Assurance will be responsible for management and continuous improvement of the GCP Quality System in compliance with regulations so that the Quality of the company’s products is maintained, the patients’ interests are protected, and the company’s quality objectives are met.  This position ensures that the company and outsourced third parties are inspection ready at all times.

Major tasks and responsibilities will include:

  • Establishes/implements clinical quality policies and procedures.
  • Provides quality oversight of internal clinical functions.
  • Provides quality oversight of all external clinical partner quality programs, including CROs, central labs, investigator sites, and other key partners supporting clinical programs.
  • Plans and conducts internal and external audits to assess compliance to the company’s procedures and GxP regulations.
  • Provides consultation in interpretation of regulations/guidelines as they apply to the GxP practice, awareness of regional regulatory requirement, and phase of study/phase of manufacturing process.
  • Enhances and maintains metrics for internal audit and vendor audit performance and compliance.
  • Performs Periodic trending of data.
  • Develops and provides GxP training to company staff.
  • Serves as a liaison with QPs at third parties for labeled IMP for release and associated QP documentation.
  • Provides QA oversight and approval of third party controlled documents (production batch records, change controls, deviations, CAPAs, temperature excursions etc.).
  • Conducts final labeled product batch review and conducts batch release for clinical trial material.
  • Provides support for the licensing (CTD/NDA/BLA or IND) approval of new products.
  • Ensures quality objectives are met.
  • Promotes a culture of total quality and operational excellence.
  • Keeps abreast of industry developments – forthcoming regulations, competitor activity, etc.
  • Serves as an SME for areas of responsibility during regulatory inspections.
  • Proposes quality improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.
  • Supports corporate and third party inspection readiness activities.
  • Provides support and contributes to other Quality Assurance activities as necessary.

We seek candidates with the following qualifications:

  • A Bachelor’s Degree in Chemistry, Biology, or Life sciences, or equivalent education is required.
  • 6-8 years of experience with Clinical Quality Systems in the drug, biopharmaceutical or medical device fields.
  • Minimum of 2 years of prior auditing experience required.
  • Experience in implementation and maintenance of Clinical Quality Systems.
  • Demonstrated knowledge of Quality Systems and cGxP within an FDA-regulated environment.
  • Must be well organized and able to grasp system concepts and communicate their applications.
  • Excellent oral and written communication skills for effectively interfacing with internal and external organizations.
  • Ability to handle multiple assignments in a fast-paced environment with changing priorities.
  • Competency in MS Office, Adobe Acrobat, and quality systems databases.
  • Ability to travel up to 20% of the time (domestic and international).
  • Ability to influence and work independently and in a team environment.
  • Negotiation and conflict management skills.

 

 

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 2792. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.