Senior QA Manager, Upstream Operations
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 and work with intelligent people who are making an impact on cancer, you will want to join the PACT Pharma team. We are a diverse work family with a dynamic and earnest culture. We are an innovative and collaborative workforce working towards one main goal - eradicating cancer!
We are located in the San Francisco bay area. 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 Sr. QA Manager, Upstream Operations to report to the Director of Quality Assurance to continue the advancement of PACT Pharma’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 PACT Pharma's 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 programs 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 to 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.
- 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 6+ years relevant industrial experience.
- 2 plus years of people management experience is required.
- Strong understanding of 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 3+ years and 5+ years total in a GMP environment.
- Demonstrated strong problem-solving and decision-making skills.
- Strong teamwork, leadership, organization, and communication skills.
- Familiarity with molecular and protein clinical screening programs.
- Must have extensive cGMP quality system knowledge and experience.
- Experience with Master Control eDMS and eQMS is desirable.
- Audit experience and/or certification are desirable.
- CLIA experience is a plus.
PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate based on race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.