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Vice President of Quality

Berkeley, CA, United States

Vice President of Quality

About the Company

Innovative biopharmaceutical company

Industry

Biotechnology

Type

Public Company

Founded

2011

Employees

201-500

Categories

Biotechnology

Pharmaceuticals

Clinical Care

Health Care

Medical Care

Therapeutics

Medicines

Precision Engineering

Manufacturing

Medicine

Chemical Products

Academic Research

Laboratory Services

Agriculture

Healthcare

Synthetic Biology

Oncology

Specialties

Next-generation CRISPR genome editing

allogeneic CAR-T cell therapies

iPSC-derived NK cell therapies

and oncology

About the Role

The Company is seeking a Vice President of Quality to lead their GxP Quality Organization and Operations, with a focus on promoting a quality mentality culture. This key role involves setting and ensuring the delivery of robust and balanced quality operations, and guiding the development of phase-appropriate systems, policies, and procedures to support clinical and commercial product quality and compliance. The successful candidate will be responsible for Quality Assurance, Quality Control, Quality Systems, and Clinical Quality, and will oversee the management of quality for both internal activities and an extensive network of external manufacturing and testing partners. Collaboration with IT to establish systems strategy and plan, as well as contributing to regulatory strategies and plans, particularly in the areas of CMC and clinical, are also integral to the position.Applicants must have a Master's degree in a technical field, a minimum of 15 years of experience in the biotech/cell & gene therapy space, and a strong background in quality management, regulatory, compliance, and quality operations supporting novel technologies. Experience with US and EU CMC, regulatory & quality expectations, and developing a quality culture that balances all competing factors is essential. The role requires an excellent people manager and cross-functional leader, with the ability to mentor and coach quality staff, lead diverse and complex teams, and influence at all levels of the organization to align quality expectations with corporate goals. The Vice President of Quality will also be expected to contribute and influence the senior leadership level of the organization beyond quality.

Hiring Manager Title

Chief Technology Officer

Travel Percent

Less than 10%

Functions

Engineering

Information Technology

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