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 an Associate Director/ Director – Quality Systems who will report to the Quality Assurance Director and continue advancing 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 GMP Quality Systems and understands biologics and/or cell therapy processes (i.e. cell culture, expansion, fill/finish, aseptic environments, reagent/media control, contamination control). The job incumbent will be responsible for implementation and optimization of Quality Systems supporting Upstream and Downstream clinical processing. This includes the following QA activities: .
- Oversee the internal and external audit program, which includes focus on cGMP compliance, regulatory agency inspection readiness, and for-cause inspections.
- Recommend systems for audit; write audit plans, coordinate scheduling, conduct and write reports to close audits. Follow-up on corrective actions.
- Review GMP quality metrics. Analyze data relating process controls, and continuous process improvement efforts. Coordinate the necessary quality adjustments.
- Conduct trend analysis and provide Senior management with corrective action proposals.
- Review relevant GMP documents for compliance to company SOPs, quality systems, and regulatory requirements.
- Oversee PACT investigations for nonconforming product, customer complaint, laboratory out-of-specification, and corrective and preventive action.
- 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 manage PACT Training program for GXP operations.
- Prior team management experience required.
- Ability to build strong working relationships with multiple departments.
- Ideal candidate holds a bachelor’s degree or higher in relevant biological sciences.
- The role demands a goal-driven approach and the ability to focus on time-sensitive objectives.
- Demonstrated understanding through prior experience of GMP regulation and guidelines related to the conduct of good manufacturing practice.
- Must have worked in clinical development as a Quality professional for a minimum of 5+ years and at least 10+ years total in a GMP environment.
- Must have strong writing skills.
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.