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 on 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 will be based at Stemcentrx, AbbVie's South San Francisco, CA location.
We are seeking an experienced QA Operations candidate that would be responsible for performing a wide variety of QA activities in support of internal GXP activities. This person would also be responsible for ensuring regulatory compliance at Stemcentrx. Provide leadership for maintaining and enhancing, in a phase-appropriate manner, the quality and compliance culture at Stemcentrx. The successful candidate will report to the Director of GMP QA at Stemcentrx, AbbVie's South San Francisco, CA location.
Key Responsibilities Include:
Independently perform and/or manage batch release activities for clinical production including but not limited to review of batch records, analytical data, certificates of analysis, and other documents as needed for consistency with applicable regulations and for compliance with company’s GMP Quality System
Provide direction for complex deviations, OOS investigations, and manage timely investigations and CAPAs in support of batch release
Review and approve SOPs, Forms, Master Batch Records or other documentation related to manufacture, testing and release of clinical product
Provide Quality support to the internal GMP manufacturing operations and facility
Identify continual improvement opportunities
Report quality issues and trends to management
Represent Quality in cross-functional teams
Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters are addressed in an open and timely manner
Support and participate in Quality improvement initiatives
B.S. or advanced degree in chemistry, biology or related science
Minimum 9 years’ experience in the pharmaceutical / biopharmaceutical industry and 4 years direct experience managing Quality
Ability to work effectively with various technical groups and a strong working knowledge in one or more of the following disciplines: API or drug product manufacturing, pharmaceutical sciences, analytical development / QC labs, GLP requirements.
Proven management skills with ability to lead others effectively and experience to advocate a quality environment
Experience with Antibody Drug Conjugates a plus
Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
Demonstrates working knowledge of quality assurance systems, methods and procedures.
Demonstrates audit and investigation skills, and report writing skills.
Demonstrates good verbal, written, and interpersonal communication skills.
Demonstrates proficiency in Microsoft Office applications.
Ability to operate in a fast-paced, multi-disciplinary industrial environment
At AbbVie, we have the expertise of a proven pharmaceutical leader and the focus and passion of an entrepreneur and innovator. The result is something rare in health care today – a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people and societies around the globe.