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Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Director, CAR-T External QA
This position will be responsible for the team providing Quality oversight of selected contract service providers (CSPs) within the CAR T network, including the contract manufacturer, material supplier, and service provider. To provide support for auditing of Celgene CAR T CSP network, including support for business development/due diligence efforts. To be responsible for monitoring and completion of audit CAPA plans for assigned CSP, including quality improvement efforts at assigned Celgene suppliers, service providers, and new/potential CSPs. To provide primary quality support for establishment of assigned new CSPs as well as implementation and routine oversight of global material suppliers and service providers.
Responsibilities include, but are not limited to, the following:
- Support the CSP Approval processes, providing guidance related to the GMP approval process and requirements in compliance with CAR T and Celgene Standards, including review of documentation received from CSP required for approval (e.g., CSP quality questionnaires and documentation).
- Support auditor in audits of Celgene CSPs as subject matter expert for CAR T.
- Support Quality Due Diligence assessments of potential new CSP or business development activities.
- Quality lead for assigned audits to ensure the monitoring and completion of audit CAPA plans/quality improvement efforts, including authority to assess CSP documentation for adequacy to close Celgene audit findings.
- Support management of the CAR T audit plan as primary interface with Global GxP Compliance for establishment of the annual audit plan, ensuring that audit requests are submitted and tracked.
- Responsible for initiating Quality Agreements with assigned new CSPs, and establishment/maintenance (periodic review/update) of any required Quality Agreements with assigned global material supplies and service providers.
- Act as Single Point of Contact to ensure all quality-related activities at assigned new CSPs, are completed according to CAR T and Celgene requirements; supporting establishment of the CSP until the formation of a project team and assignment of a CSP Oversight group responsible person.
- Responsible for ensuring a successful transition of CSP oversight responsibilities to the CSP Oversight group following the formation of a project team.
- Responsible for driving/initiating CSP global material supplier and service provider risk assessments for assigned projects, related to initial approval and routine monitoring requirements as defined in CAR T procedures and Celgene Standards.
- In coordination with Quality management, determine the appropriate strategy for Quality Oversight of global material suppliers and service providers.
- Point of Contact for all quality-related activities of assigned CSP global material suppliers and service providers, supporting approval and establishment.
- Responsible for routine monitoring and oversight of assigned CSP global material suppliers and service providers (including on-sight oversight as needed, assessment of supplier initiated changes, management of global change control, assessment of deviations, investigations, and CAPA).
- Responsible for monitoring quality trends and driving continuous improvement of the quality performance for the assigned CSP material suppliers and service providers.
- The Quality representative on the Quality Management Review for the assigned CSP material suppliers and service providers, ensuring that the CSP provides the required product review or the data as specified in the relevant Quality Agreement. Critically assess the performance of the product and process and provide the required assessment, and escalation of quality issues according to Celgene escalation policy.
- Provide additional cross-functional support for other groups within CART QA as directed by management. Within the organization:
- Support the implementation and maintenance of a local Quality System and Standard Operating Procedures for CAR T Quality.
- Ensure the QA management is kept informed of all critical and major issues which may have an adverse effect on the quality of the CAR T products or effect program timelines.
- Participate in the Reporting on CSP QA activities – this is to include Risk Assessment, reporting and managing of defined KPI’s. Monitor Key Performance Indicators and ensure that all parts of the Supplier Approval QA organization are working in a consistent manner against harmonized expectations. Initiate corrective actions when necessary and perform follow-up on resulting measures.
- Ensure that coordinated contact is maintained with other functions within Celgene also dealing with CSP namely Compliance & Auditing, Commercial BD, Clinical operations QA, Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Global Quality Operations (GQO), etc.
- Provide accurate and compliant guidance that is flexible and appropriate for the product/project phase; based on and compliant with policies/standards/SOPs established at Celgene.
Personal Development and People Development
- Training plans in place with training conducted, assessed and documented
- Execution of assigned responsibilities in a timely and efficient manner
- Robustness of risk mitigation (CAPA closure effectiveness, supplier management)
- For assigned projects, performance against established KQIs, including timeliness of CSP approval, number of overdue deviations/investigations, etc.
- Experience in QA Operations, production, QC and/or other relevant operational areas, but must include some QA experience
- Thorough knowledge of cGMP requirements
- Strong understanding of regulatory requirements for commercial products
- Interaction with health authorities (e.g. FDA, EMEA)
- Participation in GMP or GCP audits as a support or lead auditor
- 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
Education and Experience
- Bachelor Degree higher in Biology, Biochemistry, Virology, Microbiology or another related science
- Twelve or more years’ experience in the pharmaceutical industry in biotech or cell and gene therapy
- Five plus years in pharmaceutical QA
- Direct experience working with CSP manufacturing or supply relationships
- Experience in QC testing, ideally of biologics or gene and cell therapy products preferred.
- Experience as auditor for GMP or GCP preferred.
Fluent in speaking / writing in English
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.