Director Quality Assurance

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP
  3. United States
San Francisco, California
Posting date: 13 Jun 2019

ProClinical is currently seeking a Director of Quality Assurance for a clinical-stage biotechnology company, focusing on auto immune diseases and cancer. Successful candidate will be responsible for providing leadership and direction for Quality Assurance and for ensuring compliance with all relevant health authority regulations and guidelines as they pertain to manufacturing and clinical activities.

Job Requirements

  • Develop and implement Quality Assurance processes, procedures, and systems.
  • Lead strategic QA planning and risk assessments.
  • Evaluate events, incidents, queries, and complaints; initiate and perform investigations as necessary.
  • Manage corrective and preventive action plans.
  • Provide oversight of clinical research organizations, central labs, investigator sites, drug substance and drug product manufacturers, distribution centers, and other key contract service providers.
  • Perform manufacturing batch record review and release
  • Review and/or approve deviations, out of specification results, out of trend results, out of expectation results, CAPAs, and change control.
  • Support regulatory inspections; internal and external.

Skills and requirements

  • Bs requires. 8-12 years of QA experience in the pharmaceutical/bio pharm industry.
  • Experience performing GxP audits.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Excellent interpersonal skills with ability to effectively interact with different functional groups at all levels of the organization.
  • Willing to travel up to 25%.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Anna Graham at (+1) 415-660-4945 or upload your resume on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.