Adicet Bio is a well-funded, privately held, preclinical-stage biotechnology company that is engaged in the development of cutting-edge immunotherapies that have the potential to profoundly transform the treatment of cancer and other diseases and we are growing!
DIRECTOR, QUALITY ASSURANCE (QA for QC)
Adicet Bio is seeking an experienced and motivated Director of Quality Assurance. This position will be responsible for supporting contracted cGMP testing operations for Adicet’s products and supporting internal late-stage preclinical analytical test method development. The successful candidate must thrive in a fast-paced team environment, have excellent communication, planning and organizational skills, and be able to independently manage review times to meet Adicet’s priorities and communicated timelines.
The candidate will be responsible for managing quality testing aspects at external suppliers for Biopharmaceuticals / Pharmaceutical / Devices / Cell & Gene Therapies and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Adicet Bio Quality Manual and is conducted according to the relevant SOPs. This is a full-time position reporting to the Head of Quality Assurance and is located at our corporate headquarters in Menlo Park, California.
- Lead External testing labs Qualification process.
- Acts as Single Point of Contact / SPOC for all quality related activities at the External Testing Labs.
- Ensure that all aspects of the sample handling and testing of biopharmaceutical / pharmaceutical / Cell & Gene Therapy products are in compliance with the Adicet Bio Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs and methods.
- Responsible for driving / initiating External Testing Lab Quality Risk assessments to be carried out for all External Testing Labs. Gaps are Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed.
- Provide the quality presence and in-put to Technical meetings with the External testing labs and establish good working relationships with clear communication and defined actions and goals.
- Ensure that a valid QA agreement defined in line with the requirements of the Adicet Bio template is in place which clearly defines cGMP roles and responsibilities between Adicet Bio and the External testing labs, as well as Product details and requirements.
- Request, review and process testing documentation as defined by the Quality Agreement and Adicet Bio SOPs. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.
- Responsible for coordinating and ensuring that Quality auditing of External testing labs is carried out according to the Adicet Bio Quality Manual - maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at External testing labs where appropriate.
- Manage all critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Adicet Bio Quality Manual. Ensure investigations are correctly executed.
- Ensure that Change requests, either from the External Testing Labs or from Adicet Bio, are managed according to the Quality Agreement and Adicet Bio SOPs from receipt, through to the implementation and closure.
- Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance.
- Stability reports and PQR’s, Ensure that the External Testing Labs provide the required product review or the data as specified in the relevant Quality Agreement on an annual basis. Critically assess the performance of the product and process and provide the assessment to the report annually.
- Escalate any issues or instances of instability per the Adicet Bio policy, and initiate any market action that is required.
- Ensure that Analytical Method Transfers are performed according to Adicet Bio SOPs and external testing lab SOPs.
Within the organization
- Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External Testing Labs.
- Ensure that the Senior Management is kept informed of all critical and major issues which may have an adverse effect on the quality of the product at an External Testing Lab.
- Together with the Technical Operations provide direction, formulate strategies and make decisions which ensure the efficient operation of the External Testing Lab business as a whole - Participation in the Business review of External Testing Labs.
- Participate in the Reporting on QA External Testing Lab activities - this is to include Risk Assessment, reporting and managing of defined KPI’s.
- Ensure that coordinated contact is maintained with other functions within Adicet Bio also dealing with External suppliers namely Purchasing, Legal, Technical Operations, Regulatory Affairs, etc.
- Participate in projects as defined and ensure that all aspects are implemented and followed up
- Maintain current knowledge of local and international regulatory and legislative requirements and trends.
- Assist in the design, implementation and maintenance of the Adicet Quality System, including document drafting, review, finalization and training.
- Bachelor’s degree or higher in Biochemistry, Chemistry, Microbiology or another relevant scientific area.
- Minimum 10+ years experience in the pharmaceutical industry. Experience in Quality Assurance operations, QC and / or other relevant operational areas, but must include minimally 5 years in QC and 3 years of management and or project management experience. Thorough knowledge of cGMP requirements.
- Cell therapy and/or gene therapy experience is preferred
- Strong understanding of regulatory requirements for commercial products
- Proven track record with FDA, EMEA and other Health Authorities.
- Strong understanding of risk assessment and risk management fundamentals/tools
- Technical understanding of pharmaceutical processes
- Team and consensus builder, with definitive and authoritative decision making ability.
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.