Director, Global Product Quality Lead, Cell Therapy (R1559663-en-us-1)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Director, Cell Therapy Product Quality Lead (Dir. CT-PQL) will partner with the Global Product Quality Lead (GPQL) to provide direct technical and quality compliance oversight of a late-stage cell therapy product and/or vector program. The Dir. PQL will assist the Global PQL to develop and roll-out global product quality strategies relating to end-to-end Quality management of clinical / commercial manufacturing, life-cycle improvements (process, analytical), analytical control strategies (methods, specifications), stability, product complaints, and monthly Product Quality Team reviews. The Director PQL will drive strategy across multiple technical teams over different technology platforms to support implementation and risk mitigation strategies related to technology transfer, comparability, clinical filings, and life-cycle improvements (as needed). The Director PQL will be as a technical and industry expert across multiple core disciplines and/or technology platforms Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy Development Organizations to ensure regulatory compliance of GMP operations in support of the product or vector program.
This role can be in Seattle, WA, Summit, NJ or Devens, MA and reports to the Global Product Quality Lead, Cell Therapies.
The Director, Cell Therapy Quality Lead will:
- Be recognized as a technical and industry expert across multiple core disciplines and/or technology platforms. Drives strategy across multiple technical teams and provides quality oversight and support for manufacturing operations including developing and maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions.
- Actively contribute to the strategic direction of multiple disciplines and provide diverse scientific and strategic input for meeting functional objectives.
- Partner across Global Product Quality, Analytical Sciences and Technology, CT Development, CT Operations, and CT Regulatory CMC to define and deliver product quality strategies that comply with internal and external quality standards and regulatory requirements.
- Makes complex tactical and strategic decisions that have impact across the GPS enterprise. Serves as a delegate for the Global PQL in CMC/TCT meetings, Development team meetings, and general cell therapy governance meetings.
- Translates industry trends and innovative technology or strategy into business opportunities. May anticipate future trends.
- Provides technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies in support of commercial development efforts and life-cycle management activities.
- Supports Global Annual Product Quality Review deliverables for the product that include coordinating with leads of contributing chapters and ensure timely and compliant execution of the program
- Coordinates product specific presentations to the Product Quality Review Board / Product Specification Committee and other product quality related cross-functional teams
- Serves as QA reviewer / approver for development reports, product specifications, and product labeling
- Provide strategic guidance and facilitate the timely implementation of global changes with respect to the product. Owns global changes and documentation management activities as required.
- Assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase
- Provide global product quality oversight over assigned areas of responsibility and support manufacturing operations including developing and maintaining relationships with partner organizations.
- Provide quality expertise in accordance with global regulatory requirements and internal policies in support of Product Characterization, Product Specifications, Method Validation, Stability and Comparability assessments for manufacturing and site changes.
- Perform Quality review of CMC sections of regulatory submissions and responses. May author CMC sections or responses to queries, as needed.
Professional experience and qualifications
- Master’s or PhD degree in Biochemistry, Immunology, Molecular Biology, Chemistry, Biology or corresponding engineering discipline preferred
- At least 10+ years of experience in cell therapy, pharmaceutical and/or biotechnology fields in Manufacturing Operations or Quality roles
Knowledge and Skills:
The Dir. CT-PQL, is preferred to have experience in the development of quality strategies to ensure product quality throughout the lifecycle. The Dir. CT-PQL is a motivated, engaged, solutions-driven, and strategic role who supports the CT-GPQL in the advancement of quality readiness. In particular, the Dir. CT-PQL has:
- Expertise in GMP compliance, global regulations, and strong understanding of pharmaceutical product development lifecycle, with specific emphasis on gene delivery and/or cell therapy preferred.
- Experience authoring, reviewing, and representing Quality in support of both clinical and commercial regulatory submissions across multiple domestic and international jurisdictions.
- Working background in Biologics, Gene Delivery, or Cell Therapy Manufacturing
- Demonstrated ability to work cross-functionally and demonstrate decision making and problem-solving capabilities relative to Quality, compliance, technical considerations, and regulatory requirements
- Experience participating in interactions with global regulatory agencies and in the
- Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end to end enterprise) and makes the best decisions for the whole
- Capability negotiation experience to influence others in a matrix environment
- Strong collaboration, delegation and interpersonal communications skills to enable sharing critical information with project team and management.
- Demonstrated analytical and logical skills with a focus on fact-based decision making.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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