AbbVie Senior GCP Compliance Auditor in South San Francisco, California
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position is based at Stemcentrx, AbbVie’s South San Francisco, CA location.
Key Responsiblities Include: * Executing AbbVie quality system processes including those for CAPA, issue escalation, change management, documentation, and personnel qualification within the Early Phase Oncology Development environment. * Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures. * Conduct audits of investigative clinical sites to assess compliance with regulations, guidelines, policies, procedures and sponsor requirements. * Effectively communicate audit results, both orally and in writing. Review corrective action plans/audit responses for adequacy and approve if adequate. * Lead Global Process and System Audits to evaluate Affiliate offices for compliance to applicable SOPs and local regulations. * Review clinical research documents, such as research reports, to assess the quality and compliance to policies, procedures, and applicable governmental regulations. * Assist and/or lead in periodic audits to evaluate Vendor R&D facilities, equipment, personnel, methods, practices computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable governmental regulations globally. * Evaluate the potential risk of compliance deficiencies. * Review policies and procedures and suggest improvements. * Maintain effective communication of project related information. * Provide consultation and direction on complex quality assurance and GCP compliance questions from supported organizations * Initiate, manage, and/or participate in quality improvement projects. * Mentor, coach and train QA auditing staff. * Prepare and present multiple project progress reports to update management and keep the team(s) informed. * Assist in external audits by regulatory agencies or customers. * Maintain project oversight to include assessments for the development program, allocation of QA resources and awareness of project timelines. * Lead Quality team members for project specific activities as required.
Minimum Education Requirements: * Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent experience required. * Minimum Experience Required: • 5-7 years of Pharmaceutical Industry Experience in Quality Assurance / Regulatory Affairs. • 5-7 years Clinical Research Development • 2-4 years GCP QA Auditing Experience Minimum of 7 years total combined experience required. (Not necessarily the sum of the above)
Willingness to travel 50% of the time (may increase to 75% occasionally depending on business needs)
Job Classification: Experienced
Job: QUALITY ASSURANCE
Primary Location: USA-California-South San Francisco
Organization: Research & Development
Travel: Yes, 75 % of the Time
Req ID: 1705219
Equal Opportunity Employer Minorities/Women/Veterans/Disabled