Director/Senior Director, QA GCP
Director/Senior Director, QA GCP - Permanent - Onsite
Proclinical Staffing is seeking a Director/Senior Director, QA GCP to join a leading biotech company. This is a permanent role located in Redwood City, CA.
This position will collaborate with Clinical Operations and Development, Clinical Sites, CROs, Regulatory Affairs and Quality to provide quality support and oversight to ensure clinical trials are planned, conducted, completed, and records maintained in compliance with regulations, legislation, guidelines, and requirements.
Skills & Requirements:
- BA/BS degree with a minimum of 15 years' experience in the pharmaceutical industry, including at least 10 years in a clinical (GCP) quality assurance role.
- Thorough knowledge and understanding of ICH GCP and relevant regulations, legislation, and guidance's related to clinical studies and their quality oversight.
- Superior communication skills (both written and oral) are essential.
- Demonstrated ability to communicate tactfully in a multi-disciplinary team environment with prior experience communicating with external parties including regulatory agencies (e.g. FDA).
- Working knowledge of health authority inspections and inspection readiness activities.
- Experience coordinating and conducting audits of clinical sites and CROs.
- Proven proficiency in MS Word, Excel, Power Point, and Adobe Acrobat.
- 30% travel is expected.
The Director/Senior Director, QA GCP will:
- Prepare and implement risk-based audit plans for clinical studies. Coordinate/perform and/or support GCP auditing activities and observation resolution to ensure that studies are conducted in accordance with the study protocols, regulations and GCP.
- Collaborate with Clinical Operations, clinical sites and CROs to provide ongoing quality support and oversight during the set-up, conduct and completion of clinical studies to ensure participant safety and data integrity.
- Lead the GCP inspection readiness/inspection support activities at the CROs and clinical sites.
- Perform CQA reviews of clinical study protocols, Brochures, Patient Information Sheets / Informed Consent and Assent forms, and other related clinical study documents as needed.
- Develop, establish, and implement GCP clinical quality assurance (CQA) oversight and management processes and procedures. Review and approve SOPs associated with Clinical Operations and Development.
- Support the Quality group's oversight efforts with quality systems such as change control, quality investigations, CAPA identification and resolution, audits, and any other recommendations to compliance issues and/or observations as they arise.
- Report and escalate significant quality observations/risks to Quality Management.
- Facilitate and/or conduct internal clinical quality training for employees and contractors.
- Participate in solving CGP compliance issues.
If you are having difficulty in applying or if you have any questions, please contact Christina Chung at (+1) 857-233-9215 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.