Quality Recruiting. Established Experts.

Director, Quality Control

Reference Number: 2871
Location: West Coast

Our client is a biopharmaceutical company whose mission is to develop effective therapies to treat and cure cancer.  They have asked us to assist them in their search for a Director, Quality Control.

The Director, Quality Control is responsible for directing the development, implementation and administration of Quality Control (QC) activities, personnel, systems, procedures, and programs to ensure the quality and reliability of clinical materials and commercial products, as well as Quality Control for cGMP, GLP and GCP processes and systems for the company.

Major tasks and responsibilities will include:

  • Leadership and management responsibility for the QC review and oversight of development, testing, stability and validation data, documentation, and records relating to the sampling, testing, analysis, and investigation of clinical and commercial drug materials.
  • Manages and leads all QC Staff, and acts as the QC technical representative and highest level QC contact with analytical vendors, Quality Assurance, and Regulatory Affairs, and will report directly to the Senior Vice President, Global Quality.

We seek candidates with the following qualifications:

  • Bachelor’s degree in a scientific discipline such as chemistry, biology, microbiology, or similar is required.  Advanced and/or Doctorate degree in a scientific discipline preferred.
  • ASQ Certification such as Certified Quality Engineer (CQE) preferred.
  • Minimum of 15 years of experience in an FDA-regulated pharmaceutical environment performing QC functions, with a minimum of 10 years in a supervisory QC Laboratory management capacity, in analytical and quality control GMP pharmaceutical environment.
  • Experience managing quality control technical systems in an FDA-regulated environment required.
  • Experience working with aseptic pharmaceutical products/compounds.
  • Preference given to an existing QC Lab Manager or QC Director currently managing a QC Laboratory in a pharmaceutical, biotech, or medical device company.
  • Experience with Novatek systems preferred.
  • Strong experience and training in Statistical Techniques and Methods, Statistical Process Control (SPC), Statistical Quality Control (SQC), Trend Analysis, Proactive QC Methods.
  • Experience managing the QC Requirements and QC Vender Oversight for Contract Manufacturing Organizations (CMOs), and Contract Laboratory Organizations (CLOs).

 

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 2871. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.