Sangamo Therapeutics is seeking a Manager, External Quality & Product Release who will oversee the execution of key Quality System activities related to the development and GMP manufacture of the company's ZFP Therapeutic® products. Such products include recombinant Adeno-associated Viral Vectors (rAAV), gene-modified T cells and gene modified hematopoietic stem cells with manufacturing performed at both Contract Manufacturing Organizations (CMOs) and in-house.
This position assists in establishing and implementing the Company's CMC-related quality philosophy, policies, practices, procedures, standards, processes and systems. Such Quality Systems are intended to assure the compliance of product manufacturing and product quality with applicable company, FDA and international regulations and guidelines, including current Good Manufacturing Practices (cGMPs).
- Serves as Sangamo's Quality representative for CMO-related activities, such as, program meetings, site visits, documentation review/approval and investigations.
- Provides quality oversight for the review/approval of CMO documents submitted through Sangamo's External Change Control (ECC) system.
- Performs person in plant activities and provides QA oversight at CMO sites, as needed.
- Works closely with Sangamo's External Manufacturing department to ensure CMO activities are progressing to plan.
- Acts as Sangamo's primary Release Authority / Release Responsible Person.
- Manages Sangamo's Product Release team, comprised of QA Specialists and Sr. Specialists, and directs their review activities to ensure the on-time release of intermediates for further manufacturing and final products for new and on-going clinical trials.
- Reviews (internally or externally generated) production batch / test records and prepares disposition documentation for critical starting materials, ancillary supplies, drug substances, drug products and secondary packaging kits.
- Coordinates with CMO release teams to ensure timely handover of documents to Sangamo, resolution of review findings and timely Manufacturer's release. Communicates CMO delays/issues to senior management and works with both internal and external teams to reduce impact of delay and, where possible, recovering release timelines by expediting Sangamo activities.
- Manages and directs review team on real time review of internal manufacturing and testing activities.
- Performs initiation, investigation and closure activities for Deviations, CAPAs and Change Controls to ensure compliance of company's procedures and the continual improvement of quality systems
- Assists in the development and implementation of QA systems, policies and procedures in support of release activities
- Updates and maintains QA databases, and generates trending analyses and metrics as needed.
- Other activities as may be assigned.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Bachelor's degree in science or equivalent field of study.
- Minimum 5 years related experience in the biotechnology or pharma industry, ideally for Advanced-therapy Medicinal Products (ATMPs) including cell and gene-based therapies. Minimum 2 years in a supervisory (team lead) role.
- Progressive experience in a review role, either in QA manufacturing or QC. Attention to detail a must.
- In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements ideally for ATMPs.
- Experience with cell-based, gene-based and rAAV-based therapies a plus
- Excellent interpersonal skills.
- Outstanding organizational skills.
- Excellent written and oral communication skills.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment