Manager, Quality Assurance

Role Summary

The incumbent is responsible for leading and overseeing day-to-day Quality Assurance (QA) operations for the LyFE manufacturing facility, including leadership for the QA team. This role has primary responsibility for drug product batch disposition and collaborates closely with the LyFE GMP Manufacturing Center teams to support technology transfers and continuous improvements of GMP processes. The incumbent will perform and oversee routine Quality Assurance activities, including but not limited to batch record review and disposition, raw material disposition, and approval of records (e.g. deviation, CAPAs, change controls, and nonconformances). This role also supports broader Quality Operations activities to ensure compliance, operational excellence, and product quality.

Responsibilities

• Responsible for supporting Quality oversight of GMP operations at the manufacturing facility and ensuring adherence to applicable GMP regulations and Lyell policies and procedures.
• Responsible for ensuring drug products are promptly dispositioned at the appropriate stages (Release for Infusion, Release for shipment etc.) to ensure on time product delivery to patient.
• Perform review and approval of executed electronic batch records, including the identification and investigation of deviations with cross functional personnel.
• Provide on the floor quality support for applicable manufacturing operations in the cleanroom facilities during operations (potentially including non-routine working hours and holidays).
• Perform routine QA activities including incoming patient apheresis receipt, drug product packaging operations, drug product disposition and audit support.
• Perform routine raw material review and disposition and approval of raw material.
• Provide quality oversight as well as review and approval of QMS records (Deviations, Change Controls, Excursions, CAPAs, Non-Conformances, Complaints).
• Maintain Quality Key Performance Indicators (KPIs) to achieve business goals.
• Represent Quality Assurance on project specific teams for clinical products.
• Collaborate with other leaders at the site to assist in the continuous improvement, lifecycle management of GMP procedures and BLA/PLI readiness activities.

Qualifications

• Required: Experience in cGMP clinical manufacturing; experience with electronic quality management systems (e.g. deviations, CAPAs, change management); demonstrated ability to lead, mentor, and develop team members; proven capability to oversee QA operations and workflows; ability to work independently and cross-functionally with multiple departments; excellent communication, emotional intelligence and interpersonal skills; proactive continuous improvement mindset; fast learner and adaptable to a fast-paced environment; excellent analytical and scientific/technical expertise.
• Preferred: BS with a minimum of 10 years’ experience in biochemistry, chemical engineering, bioengineering, or related scientific field; or MS with a minimum of 7 years’ experience in biochemistry, chemical engineering, bioengineering, or related scientific field.
• Preferred: Minimum of 10 years of experience in cGMP biopharmaceutical manufacturing operations including 2 years in cell therapy and/or lentiviral manufacturing operations; minimum of 3 years of experience managing people in technical GMP roles; minimum of 3 years in GMP Quality Assurance and/or extensive experience with quality management systems (e.g. Deviations, CAPAs, Change Controls).

Skills

• Experience in cGMP clinical manufacturing
• Experience with electronic quality management systems (e.g. deviations, CAPAs, change management)
• Leadership, mentorship, and people development
• QA operations and workflow management with timely execution and compliance
• Cross-functional collaboration with Manufacturing, MSAT, Regulatory, Patient Operations, Supply Chain, and external partners
• Excellent communication, emotional intelligence, and interpersonal skills
• Continuous improvement mindset; risk identification and sustainable quality solutions
• Fast learner, adaptable to start-up environment
• Strong analytical and technical expertise

Education

• Preferred: BS with a minimum of 10 years’ experience in biochemistry, chemical engineering, bioengineering, or related scientific field; or MS with a minimum of 7 years’ experience in biochemistry, chemical engineering, bioengineering, or related scientific field

Additional Requirements

• Physical demands include visual verification of batch records and SOP steps, inspection of materials and equipment, and ability to stand and gown for aseptic operations.
• Occasional shift work, weekend work, and holiday coverage may be required due to the nature of autologous cell therapies and timely delivery to patients.