Head of Quality Assurance (Director or Sr. Manager)
PACT Pharma is an exciting new company with laboratories currently located in the San Francisco Bay Area. PACT is developing personalized adoptive T cell therapies for the eradication of solid tumors. The identification of neo-epitopes that serve as private mutations for each patient’s cancer creates a unique opportunity to engineer autologous T cells that target and kill tumors expressing these neo-antigens. PACT utilizes technology licensed from the laboratories of Drs. Heath and Baltimore (Caltech) to identify T cells that recognize the neo-epitope. The unique T -cell receptor (TCR) sequences obtained from these neoepitope-reactive cells are then engineered into T cells from the patient’s own blood to produce PACT’s therapeutic product: a tsunami of fresh, active T cells that, following infusion into the patient, recognize and attack each patient’s cancer cells.
We are currently recruiting a highly qualified Head of Quality Assurance (Manager/Director-level or above) to be responsible for creating, supporting and providing oversight of quality systems according to procedures, standards and regulations in a start-up environment.
We are currently located in the San Francisco bay area, in the heart of the world’s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. PACT Pharma is an ambitious cutting-edge undertaking - we fully anticipate our company to become the world’s leader in personalized adoptive T cell therapies for cancer and therefore key to the future of cancer treatment.
Head of Quality Assurance (Sr. Director, Director, Associate Director or Sr. Manager)
The Head of Quality Assurance must be able to assess projects from a QA standpoint using a broad understanding of the FDA and international requirements and be able to comply with GMP. The director must be able to develop and implement the quality strategy. This employee will be a member of cross-functional project teams and also the liaison with FDA as well as business partners in quality matters. The director ensures budgets, schedules and performance requirements are met.
- Represent QA on project teams and in joint alliances as required. Direct all aspects of quality support and strategy for the project team on the designated product (s).
- Lead, facilitate and coordinate quality meetings for the assigned project. Responsible for FDA liaison during audits.
- Initiate and update quality strategic plans for the projects and coordinate with the project leader for incorporation into a product development plan. Assess pros, cons and risks of the various strategic options and communicate to the project team and management.
- Direct development, initiation and maintenance of all quality systems in support of the product(s).
- Review and approve all documents used requiring a quality assessment (including protocols and reports).
- Ensure the project team objectives and timelines are supported by quality deliverables.
- Keep abreast of all pertinent laws, regulations and guidance relevant to specific product areas.
- Provide expertise in the interpretation of regulations and guidance relating to product development from a quality perspective.
- Coordinate with consultants and contractors as required.
- Manage, train and direct quality associates and managers reporting to the director.
- At least 10 years US Quality Assurance experience and at least 12 years total biologics industry experience
- Experience with a start-up company in Pre-IND phase is preferred
- Minimum of BS in a relevant scientific discipline
- Broad understanding of drug development
- Experience of serving on a project team
- Competency in FDA/International GMP requirements is essential. Global experience a plus
- Excellent verbal and written skills
- Flexible mindset and ability to multitask