Director, Quality Assurance Operations
Adicet Bio is seeking an experienced and motivated Director, Quality Assurance Operations. The Director, of QA Ops is responsible for building and leading the QA Operations team and establishing relationships with internal personnel and external consultants/contractors, as necessary to support QA activities and responsibilities. This position will work cross-functionally with other departments such as: Manufacturing, Facilities, QC, Supply Chain, IT, MSAT, Process Development, Regulatory, Program Management, etc.
The successful candidate must thrive in a fast-paced team environment, have excellent communication, planning and organizational skills, and be able to independently manage timelines to meet Adicet's priorities and communicated goals. The successful candidate will have working experience and knowledge leading cGxP QA activities during clinical development and commercialization of drug candidates. The ideal candidate must have experience in providing QA support for regulatory submissions of quality-related sections.
The candidate will be reporting to VP of Quality Assurance and is responsible for the strategic development and management of QA operations to support CMC operations and clinical activities in compliance with FDA, ICH, EMA regulations, guidances, industry standards, and company policies. This opportunity is located at our corporate headquarters in Redwood City, California.
KEY 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. Will lead by example to 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.
- Partners 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.
- Provides oversight for the raw material program, including raw material QA release.
- Develop and implement procedures, programs and policies that support quality assurance functions and assure cGxP compliance.
- Supports regulatory submissions of quality related sections.
- Be a champion for continuous improvement. Identifies and drives continuous improvement initiatives and monitors progress of deliverables.
- Other duties as required.
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
- Demonstrated 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.
- Travel as required.
- Prior cell therapy experience is a plus.
BENEFITS
Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.
Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.