Director, Clinical Quality Assurance

4 weeks ago

South San Francisco, United States GQR Full time

Title: Director, Clinical Quality Assurance

Location: South San Francisco

Status: Full-time direct hire; Hybrid role 3 days a week onsite


The Director of Clinical Quality Assurance (CQA) is a hands-on position responsible for ensuring clinical trials adhere to applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH guidelines, Standard Operating Procedures (SOPs), and current industry standards and practices. The candidate will support clinical compliance and inspection readiness. This position will be reporting to the Senior Director, CQA.


Responsibilities:

  • Represent clinical quality at the program team meetings and provide operational quality guidance to the development teams.
  • Represent clinical quality at CROs operational meetings, service provider meetings, and service/vendor quality meetings.
  • Provide quality oversight of the ongoing clinical programs, ensuring that the appropriate assessment and monitoring, risk assessment and risk mitigations are in place.
  • Review clinical trial documentation for data integrity and compliance with Good Clinical Practice and regulations including key clinical and IND/NDA enabling documents.
  • Provide clinical quality support for Health Authority Inspections, service providers and CROs operational meetings, as well as inspection readiness activities.
  • Collaborate with Clinical Development (including PV/Safety), Regulatory Affairs, and Development Operations (including Clinical Operations, Data Management, and Biostatistics), CROs and clinical sites to support overall GCP compliance and inspection readiness.


Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.

  • Bachelor’s degree with 12 years’ experience required or advanced degree in a scientific field with 10 years’ experience preferred. Quality assurance professional certification is a plus.
  • At least 5 years of experience in Clinical Quality Assurance or Clinical Operations.
  • Broad knowledge of risk-based quality systems approaches consistent with ICH E6 (R2) for Good Clinical Practice. Experience with all phases of clinical trials.
  • Knowledge and practical application of ICH E8 (R1)
  • Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines including understanding and application of domestic and international regulatory requirements.

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