Director, Quality Assurance Operations

About the role

The Director, Quality Assurance Operations at Adicet Bio, Inc. is responsible for building and leading the QA Operations team and establishing relationships with internal personnel and external consultants/contractors to support QA activities and responsibilities. This position works cross-functionally with departments such as Manufacturing, Facilities, QC, Supply Chain, IT, MSAT, Process Development, Regulatory, Program Management, etc.

Responsibilities

• Ensure current Good Manufacturing Practices (cGMPs) compliance for clinical manufacturing of phase I/II/III investigational product, and compliance to 21 CFR Parts 210, 211, ICH Guidelines and EU GMPs as applicable.
• Accountable for lot disposition activities including batch record review, in-process/release and stability testing review, oversight of quality events relating to GMP product, process, or facility, etc.
• Partner with cross functional groups to meet company objectives in compliance with applicable regulatory guidelines.
• Review approval of development activities in preparation for GMP such as development studies/reports, engineering activities, etc.
• Collaborates with cross functional teams and champions the Quality Risk Management Program.
• Responsible for the phase appropriate validation program.
• Serves as team leader in quality related discussions, investigations, risk assessments, change controls, etc. to resolve potential product quality issues and to ensure they are appropriately addressed and justified.
• Pairs with Facilities and functional SMEs to support equipment qualifications and lifecycle management.
• Collaborates with Quality Systems to manage the cGxP training program for internal manufacturing related functions.
• Represents the organization during third-party audits and inspections as required.
• Provides technical expertise and guidance in conducting investigations in regard to quality deviations, laboratory investigations/change controls systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution.
• Develops and implements procedures, programs and policies that support quality assurance functions and assure cGxP compliance.
• Supports regulatory submissions of quality related sections.
• Identifies and drives continuous improvement initiatives and monitors progress of deliverables.

Qualifications

• Bachelor’s Degree in scientific or relevant disciplines in life sciences.
• 10+ years of experience within the life sciences industry, preferably biotechnology, pharmaceuticals, or other regulated therapeutic environment with 6+ years in a Quality Assurance role.
• 5+ years of direct management experience.
• Mastery of cGMP regulations and quality systems.
• Thorough knowledge of applicable regulatory requirements (FDA CFR, EMA, ICH, ISO, any other global laws/regulations).
• Experience with Health Authority Inspections.
• Proficiency with electronic management systems (such as LIMS, eQMS).
• Strong interpersonal and communication skills: written and oral.
• Outstanding planning, organization, and multitasking skills.