Career Opportunities in the Foresite Capital Network

ImmPACT Bio is looking for an exceptional individual to join our growing team as Director, Quality Assurance Operations. This position will report directly to the Head of Quality and be responsible for Quality oversight to ensure patient safety and compliance with FDA and other applicable health authority requirements. The QA oversight will cover manufacturing floor duties, compliance activity support, and duties related to routine product release. This role may also support other QA operations as required, but the primary responsibility will be Quality oversight of Production and Supply Chain Operations. The QA Operations Lead is also responsible for supervision of a team of QA personnel.

Primary Responsibilities:

• Must have the knowledge and experience to provide strong leadership in support of cGMP manufacturing, testing and release of CAR-T cell therapy products.
• Provide QA oversight of production and supply chain operations through review/approval of test records for batch release, SOPs, C of As (as applicable), CAPAs, Deviations, change controls, and shop floor oversight. Provides the production and supply chain teams with QA/Compliance guidance and decisions.
• Lead in establishing/implementing QA Operations programs related to manufacturing floor programs which includes oversight of aseptic operations, GEMBA walkthrough program, equipment/area/utility out of service program, QA area release of classified and unclassified areas, QA media fill oversight programs, event triage and support of routine operations.
• Lead in establishing/implementing QA Operations programs related to batch record review and release activities which standardizes the review and release process to ensure efficient and timely product release for clinical and commercial products. Serve as Quality Lead for materials and batches to assess deviation impact, investigation needs and thoroughness.
• Lead daily operational initiatives. The successful candidate will have a proven track record of operational execution while retaining high quality of the deliverables.
• Serve as SME for QA operations to support all regulatory inspections. Provide leadership during any periodic internal production, engineering, and supply chain self-inspections. Provide leadership and guidance during the preparation and participation of health authorities’ inspections Support and regulatory filings.
• Manage and mentor Quality management staff to emphasize positional responsibility, personnel development and succession planning throughout the unit. Must be able to mentor Quality personnel in the necessary skills to review and approve highly technical documentation.
• Participate in interdepartmental/site leadership and operational excellence initiatives. Interact with other functional areas to define and execute project requirements and objectives and maintain compliance across the site.
• Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
• Candidate must have track record of working effectively in teams to resolve issues and elevate as appropriate. Ability to teach intent and common industry implementation of the Quality Systems is essential.
• Ability to prioritize and multitask necessary.

Qualifications:

• B.S./M.S./PhD plus a minimum of 10 years of relevant experience in a clinical and/or commercial manufacturing operation, manufacturing sciences, technology, or manufacturing technical support role. Cell therapy-based therapeutics such as CAR-T, or other cell-based products is a plus.
• A minimum of ten (10) years of cGMP Quality experience (QA/QC/Validation)
• A minimum of eight (8) years in roles of increasing management responsibility in Quality Assurance in a biopharmaceutical manufacturing environment
• Proven track record and practical experience in leading a quality operations unit that operated in full compliance with global cGMP requirements and successfully managed inspections from major Health Authorities including FDA and other regulatory bodies.
• Strong communication skills: oral/written and listening
• Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
• Interpersonal skills: team building, consensus building, conflict resolution
• Experience with cell and gene therapy products, manufacturing, and testing
• Self-motivated with a strong sense of ownership in areas of responsibility and willing to accept temporary responsibilities outside of initial job description.
• Possess meticulous record-keeping skills, be highly organized, with strong attention to detail along with excellent communication and interpersonal skills.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.