Director, Clinical Quality Assurance
Location: South San Francisco, CA
Position type: Full-Time
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a biotechnology company discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime's comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company's R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.
Reporting to the Vice President of Quality, we are seeking a motivated and ambitious individual to join the Quality team as Director, Clinical Quality Assurance. This individual will provide compliance leadership and work with quality management, external auditors, in conjunction with clinical development departments to ensure GCP compliance across all Five Prime projects. Additionally, the position will provide compliance oversight of pharmacovigilance activities within the organization, and be responsible for implementing clinical compliance plans, including external GCP audits of clinical service providers, CROs, suppliers, and investigator sites, and internal audits of trial master files, and clinical and pharmacovigilance processes and procedures.
Responsibilities will include the following:
- Serve as the subject matter expert in GCP, develop standards and promote collaboration with Clinical Development and CRO to design and implement risk-based GCP quality systems and processes.
- Formulate GCP compliance strategy and provide advice for all FivePrime studies and programs.
- Develop and implement audit strategies for each clinical program.
- Plan and manage GCP and GLP compliance audits (international and domestic), including clinical investigator sites, contract clinical laboratories and CROs; to determine compliance status and identify compliance risks. Conduct a portion of such audits.
- Manage the preparation of audit reports and report audit findings to management with recommendations for resolution. Verify appropriate corrective actions have been implemented and documented.
- Partner with Clinical Development stakeholders, including Regulatory Affairs, Clinical Operations, Clinical Development and Pharmacovigilance/Safety, regarding compliance issues and provide compliance guidance to audited parties to encourage process improvement.
- Establish quality agreements with clinical CRO managing FivePrime’s clinical study activities.
- Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
- Play a lead role in regulatory authority inspections and interact with agencies on GCP related matters and the coordination of responses to resolve inspection findings.
- Develop and facilitate GCP/GLP training for functional areas and personnel involved in the execution of clinical trials and nonclinical studies.
- Participate in quality and compliance improvement initiatives within and outside of Clinical Development.
- Participate in the evaluation, qualification and selection of CROs and other clinical and nonclinical service providers and support due diligence activities.
- Serve as an expert and provide guidance on and interpretation of GCP and GLP regulations, standards and quality systems.
- BS/BA degree in scientific discipline from an accredited college or university or equivalent experience. Advanced degree preferred
- 10 years of relevant pharmaceutical industry experience with a minimum of 4 years of GCP compliance experience
- In-depth knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations and guidelines
- Experience in planning and conducting GCP and GLP audits
- Experience with regulatory inspections and inspection readiness (EU experience and experience with pharmacovigilance QA is a plus)
- Experience with Quality Management Systems (e.g. documentation and records management, change control, deviations, investigations, training, and CAPA programs)
- Experience reviewing and auditing study-related documentation (e.g. study reports, Investigator Brochures)
- Experience in the use of relevant computer systems used in clinical and non-clinical research including safety databases
- Familiarity with signal detection systems is a plus
- Excellent interpersonal and written communication skills
- Ability to influence and negotiate effective solutions
- Strong critical thinking and decision-making skills
- Must be able to travel up to 30%
Please submit your resume.