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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.
Sr Director, CAR-T Quality Assurance
The Sr. Director Quality Assurance provides direction, development, and technical guidance to QA Staff and maintains responsibility for assuring that all CAR T products meet technical specifications and comply with regulatory requirements. The position will be responsible for Celgene clinical and commercial manufacturing facilities, external contract service providers, CAR T supply chain and logistics and Quality oversight to support the commercialization of CAR T products.
Champions improvement projects to promote operational and quality excellence at all levels of organization. Strategic input into complex CAR T clinical programs. Facilitates senior management decisions by presenting ideas, recommending solutions and offering goal-oriented, timely advice on quality issues.
Responsibilities include, but are not limited to, the following:
Lead CAR T Quality Assurance
- Ensure that all products manufactured at Celgene sites and CSPs site are produced, tested, and released in compliance with SOPs, cGMPs and global regulations. Ensures systems, resources, and action plans are reviewed and decisions made to attain sustainable compliance.
- Oversee decisions regarding quality control and compliance for all batches (investigations, retesting and re-inspections). Makes full batch rejection and recall decision in conjunction with Executive Director, quality Ops.
- Oversee the establishment of all systems, procedures and specifications affecting product quality.
- Oversight for CSP approval processes including CSP, material supplier and service provider approval.
- Oversight for Quality Agreements with CSPs and maintenance of agreements.
- Support/lead regulatory health authority inspections.
- Represent the site for establishment of Company-wide quality policies, strategies and practices.
- Establish and manage the Quality Operations budget for CAR T.
- Direct initiatives that accomplish continuous improvement and cost effectiveness and enhance efficiencies and compliance of processes and procedures.
- Verify that necessary actions have been properly taken to ensure continuous improvement.
- Work closely with QA management to determine the appropriate Quality strategy for oversight of global material suppliers and service providers.
- Quality oversight to support commercialization of CAR T products, assign representatives to participate in technical commercialization teams.
- Oversight for global supply chain and logistics including apheresis collection centers, blood banks, warehouses and couriers/transport providers.
- Must have expert GMP, Quality, and risk management knowledge that impacts the department or global function.
- Must have experience in the pharmaceutical industry supporting Biotech and or Cell and Gene Therapy.
- Must be able to critically interpret problems and effectively communicate in an impactful manner to management, the group, and the broader organization with clarity and a high level of brevity and accuracy.
- Must be a technical/scientific expert. Must be able to measure technical/scientific attributes in qualitative ways and drive science based decisions across the organization.
- Must manage technical teams across the organization.
- Must have experience supporting/leading health authority inspections.
- Must be skilled in strategic thinking, managing through systems, navigating politics, innovation management, and negotiation. Must possess a strategic perspective, leading vision and values, global acumen, and leadership disposition.
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.
- Ensure all unit staff receive training cGMP’s SOPs, Company Policies and safety, and that employees meet defined qualification requirements for the position to which they are assigned.
- For assigned projects, performance against stablished KQIs, including timeliness of CSP approval, number of overdue deviations/investigations, etc.
Education and Experience
- Bachelor’s degree in a scientific discipline with at least 16 years previous experience in GMP manufacturing
- Ten or more years’ experience in the pharmaceutical industry in biotech or cell and gene therapy.
- Ability to communicate effectively and function cooperatively with other staff, management and auditors. Ability to supervise and schedule staff.
- Five plus years in Pharmaceutical QA
- Experience working with CSP manufacturing or supply relationships.
- Knowledge of current regulations governing Development of Biologics and Pharmaceutical GMPs and the ability to apply to the relevant development, manufacturing, and quality control areas.
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.