Associate Director, Quality Assurance Validation
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.
As part of a talented and multi-disciplinary team advancing an exciting novel approach to drug development, the QA Validation Senior Manager/Associate Director will support qualification of computerized systems and equipment, as well as method validation for GMP and GLP applications.
The successful candidate will be responsible for providing strategic leadership and technical expertise overseeing in-house validation and external validation/transfer activities as the company progresses through early stage clinical trials. This is a hands-on role that requires close collaboration with Quality Control, Process Sciences, Manufacturing, IT and Regulatory groups.
- Manage the validation system from a Quality Assurance perspective to ensure quality and compliance requirements are met in an efficient and effective manner, and in support of corporate objectives
- Provide guidance on qualification/validation issues.
- Act as the validation SME for Equipment Change Controls supporting GMP/GLP systems.
- Ensure required Standard Operating Procedures and systems are implemented to support internal and external validation programs for antibody intermediates, small molecule intermediates, antibody-drug conjugate drug substances and drug products.
- Quality oversight and approval of software, equipment/facility qualification, IQ/OQ/PQ protocols and reports and associated change control systems.
- Ownership of the Site Validation Master Plan.
- Quality oversight and approval of internal and external method qualification, method transfer and method validation project plans, protocols and reports.
- Quality oversight and approval of internal and external process characterization project plans, protocols and report.
- Report validation/qualification quality issues and trends to management.
Candidate must possess:
- B.S. or advanced degree in chemistry, biology or related science with minimum of 8 years of experience in the pharmaceutical / biopharmaceutical industry and 4 years of direct experience managing validation activities from a quality assurance perspective
- QA experience overseeing equipment/system, method and/or computer validation activities
- Experience with implementing and/or upgrading computerized systems
- Demonstrated working knowledge of current Good Manufacturing Practices (GMPs)
- Ability to lead others effectively on multi-disciplinary teams
- Experience with quality oversight of method transfers to external contract labs
- Excellent interpersonal skills, organizational skills and both written and verbal communication skills including the ability to influence collaborators in other departments
- Ability to operate in a fast-paced, multi-disciplinary industrial environment