Associate Director, CAR-T Quality Supply Chain and Logistics
Other Locations:US- NJ- Summit West
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.Scope:
This position will be responsible for the team providing Quality oversight of selected contract service providers and service providers within the CAR T network, including Apheresis Operations, warehouses and couriers/transport providers. To provide support for the approval and establishment of apheresis blood donor collection centers including assessments and potential training and routine oversight of warehouses and contract/transport providers.
Responsibilities include, but are not limited to, the following:
- Support the starting material (apheresis centers, blood banks) approval processes, providing guidance related to the GMP approval process and requirements in compliance with CAR T and Celgene Standards.
- Support auditor in audits of Celgene starting material and service providers as subject matter expert for CAR T. Support Quality Due Diligence assessments as needed.
- Quality lead to ensure the monitoring and completion of audit CAPA plans/quality improvement efforts, including authority to assess documentation for adequacy to close Celgene audit findings.
- Responsible for initiating Quality Agreements with assigned collection centers and service providers. 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 are completed according to CAR T and Celgene requirements.
- Responsible for driving/initiating risk assessments for assigned projects, related to initial approval and routine monitoring requirements as defined in CAR T procedures and Celgene Standards.
- Act as Single Point of Contact for all quality-related activities of assigned global starting material suppliers and service providers, supporting approval and establishment.
- Responsible for routine monitoring and oversight of assigned global starting 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).
- Support approval and establishment of human cells and tissue (HCT) starting material suppliers (e.g. apheresis blood donor collection centers, blood banks), including potential site assessments, site/collection center training, and coordination with internal Celgene groups (e.g. clinical operations) where applicable.
- Manage the routine monitoring and oversight of HCT starting material suppliers (including on-sight oversight as needed, assessment of supplier initiated changes, management of global change control, and assessment of deviations, investigations, and CAPA).
- Responsible for providing support for shipper qualification and shipping deviations, CAPAs. Working closely with a cross functional team to confirm a robust Chain of Identity process is in place.
- Provide additional cross-functional support for other groups within CAR T 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 QA and the functions of the Supplier Approval group.
- Ensure the QA management is kept informed of all critical and major issues which may have an adverse effect on the quality of the CART products or effect program timelines.
- 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 including Quality, 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
- Maintain current knowledge of local and international regulatory and legislative requirements and trends.
- Support development of QA associates with respect to product and process knowledge.
- Provide mentoring of junior QA associates
Key Performance Indicators:
- 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 or higher in Biology, Biochemistry, Virology, Microbiology or another related science
- Ten or more years' experience in the pharmaceutical industry in biotech or cell and gene therapy
- Five plus years in pharmaceutical QA
- Direct experience with blood products, or blood banking, or HCT (e.g. blood collection; apheresis), or HCT eligibility assessments is preferred
- Experience working with CSP manufacturing or supply relationships
- Fluent in speaking / writing in English
#LI-POSTCelgene 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.