PACT Pharma is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient’s individual tumor and engineering T cells to kill that specific tumor.
If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team. We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!
We are in the San Francisco bay area, the heart of the world’s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.
We are currently recruiting for a Quality Assurance Director, Upstream Operations to report to the Vice President of Quality Assurance to continue advancement of PACT’s cutting edge engineered cell product. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.
What you will do:
The ideal candidate is an experienced Quality Assurance leader with a track record of success in ATMP/ GMP operations with experience in bioinformatics, gene editing, and protein science which makes up PACTs clinical screening process. An understanding of clinical diagnostics, clinical laboratory screening and autologous clinical processing is desired.
The job incumbent will help to build the Quality Assurance program, lead and mentor QA staff that support the following QA activities:
- Manage review and release of patient screen data to support autologous Cell Therapy clinical production.
- Provide QA oversight and collaborate with operations to develop quality requirements and streamline the process and documentation to ensure compliance.
- Partner with operations to build Standard Operating Procedures for process, equipment and supporting programs.
- Oversee training program and materials for clinical screening production staff.
- Provide Quality insight into QMS processes; Change Control, Deviation/ CAPA generation, Risk Management
- Review GMP quality metrics. Analyze data relating process controls, and continuous process improvement efforts. Coordinate with operations for the necessary quality adjustments.
- Review relevant GMP documents for compliance to company SOPs, quality systems, and regulatory requirements.
- Build an effective Quality Assurance team to support QA operations
- Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.
- Participate in or lead teams for special projects as assigned.
- Develop and work with staff to implement quality process controls relating to all areas of operation, including the following systems: quality, facilities and equipment, materials management, production, packaging, and labeling.
- Bachelor’s degree or higher in a relevant scientific discipline – Bioinformatics, Biology, Biochemistry, or Chemistry with minimum of 10 years relevant industrial experience.
- Prior management experience required.
- Extensive experience with regulatory inspection and knowledge of their requirements. Ability to build strong working relationships with cross-functional departments.
- The role demands a goal-driven approach and the ability to focus on time-sensitive objectives.
- Demonstrated understanding through prior experience of ATMP/ GMP regulation and guidelines related to the conduct of early phase clinical programs.
- Must have worked in clinical development as a Quality professional for a minimum of 5+ years and at least 8+ years total in a GMP environment.
- Demonstrated strong problem-solving and decision-making skills.
- Strong teamwork, leadership, organization, and communication skills.
- Extensive cGMP quality system knowledge and experience is required
- Experience with Master Control eDMS and eQMS is desirable
- Audit experience and/or certification is desirable.
- Familiarity with molecular and protein clinical screening programs
- CLIA experience desired
PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.