External Supplier Quality Manager (CONTRACT)

Location
Menlo Park, California, United States
Posted
Dec 21, 2020
Ref
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Required Education
Bachelors Degree
Position Type
Full time
Adicet Bio, Inc. is a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors and T cell receptor-like antibodies to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. For more information, please visit our website at http://www.adicetbio.com.

EXTERNAL SUPPLIER QUALITY MANAGER (CONTRACT)
  • Responsible for managing quality aspects at external suppliers for cell and gene therapies and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Adicet Quality Manual and is conducted according to the relevant SOPs.

The position will report to the Associate Director, Manufacturing Quality Assurance.

RESPONSIBILITIES:

The successful incumbent will be responsible for managing quality with external manufacturing organizations. The position will require regular interaction with the Senior Leadership on matters concerning QA compliance and inspection readiness related to product manufacture and testing. This may include, but is not limited to:
  • Lead External Suppliers Qualification process.
  • Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier
  • Ensure that all aspects of the handling, manufacturing and distribution of cell and gene therapies products are in compliance with the Adicet Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs.
  • Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. 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 suppliers 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 template is in place which clearly defines cGMP roles and responsibilities between Adicet and the External Supplier, as well as Product details and requirements.
  • Request, review and process GMP documentation as defined by the Quality Agreement and Adicet 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 suppliers is carried out according to the Adicet 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 suppliers 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 Quality Manual. Ensure investigations are correctly executed.
  • Ensure that Change requests, either from the External Supplier or from Adicet, are managed according to the Quality Agreement and Adicet 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 Supplier provides 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 to Adicet Leadership and initiate any market action that is required.

Within the organization
  • Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External suppliers.
  • Ensure that Leadership and the Technical Operations Lead is kept informed of all critical and major issues which may have an adverse effect on the quality of the product at an External Supplier
  • Together with the Technical Operations Lead provide direction, formulate strategies and make decisions which ensure the efficient operation of the External Supplier business as a whole - Participation in the Business review of External suppliers.
  • Participate in the Reporting on QA External Supplier 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 also dealing with External suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Regulatory Affairs, etc.
  • Participate in the Adicet Quality Plan - ensure that all quality issues at External suppliers are included in this plan
  • Participate in projects as defined and ensure that all aspects are implemented and followed up

Personal development
  • Maintain current knowledge of local and international regulatory and legislative requirements and trends

QUALIFICATIONS AND REQUIREMENTS:
  • Bachelor's degree in chemistry, biology, microbiology, industrial pharmacy or other related scientific discipline with a minimum of 10 years' experience in QA oversight of pharmaceutical quality control in a global environment
  • Experience establishing and managing a global QC
  • Experience in QC testing of small molecule and biologics
  • Experience performing PAI readiness inspections and hosting regulatory inspections
  • Practical knowledge of GMP and an ability to apply sound judgment and decision-making skills (risk based and appropriate for the phase of clinical development) in order to evaluate product release.
  • Working knowledge of US and EU cGMP regulations and guidelines.
  • Experience in auditing suppliers and CMO's
  • Strong planning and time management skills and ability to prioritize own work.
  • Strong leadership and influencing skills a must.
  • Travel required - approximately 20%
  • 10 or more years' experience in the cell and gene therapy/biologics industry. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and or project management experience.
  • Thorough knowledge of cGMP requirements:
    • 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