Principle Product Quality Lead, Early Development, Cell Therapy (R1557685-en-us-2)
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 PQL must drive alignment across cell therapy programs that are appropriate to the clinical phase, regulatory expectation and global compliance requirements. The individual will provide technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet product goals. The PQL will develop and roll-out product quality frameworks relating to end-to-end Quality management of clinical manufacturing, life-cycle improvements and control strategies to progress programs to commercial readiness.
The PQL is a matrixed leader able to plan for strategic implementation of late stage clinical requirements while supporting the progress of the program in the rapidly evolving cellular therapeutic field. The Product Quality Leader has responsibility for working directly with QC, QA, Manufacturing, Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy Development Organizations on the resolution of issues associated with process/manufacturing, control strategy, analytical methods, specifications, reference standards, stability, investigations, change control, product complaints and regulatory submissions.
The PQL has oversight and decision authority over multiple aspects of the cell therapy program as it moves through clinical development, including regulatory filings and supporting development reports.
- Provide global product quality oversight and support for external manufacturing / partnerships and internal manufacturing operations including developing and maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions.
- Supports the overall product quality strategy based on CMC / TCT deliverables, PD team objectives, life-cycle improvements, and regulatory commitments.
- Provides technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies in support of clinical development efforts and life-cycle management activities.
- Review clinical and commercial regulatory filings as needed.
- Develop and refine the Guidances for product quality requirements along the development continuum
- Demonstrate the ability to influence others through persuasive interactions and garner support for novel solutions where applicable.
- Show the capacity to operationalize theoretical concepts into actionable plans and execute those plans with successful outcomes.
- Coordinates Product Quality Team meetings between Site QA/QC, Analytical Development, Process Development, Manufacturing Sciences and Technology, Product Sciences, and Regulatory Affairs.
- Coordinates program 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, stability reports, and product specifications
- Supports Quality oversight and pivotal readiness for early stage programs, providing strategic guidance and facilitation of changes pertinent for pivotal and eventually commercial success
- Provide strategic guidance and facilitate the timely implementation of global changes with respect to the assigned 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
Qualifications and Education Requirements
- BS/MS in relevant Science or Engineering discipline and 10+ years of experience in Quality in a biotech, pharmaceutical, or bio-pharmaceutical organization; 1-3 years of experience in a supportive PQL role is preferred
- Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle are required
- Experience with review of market applications, IND, supplements or similar regulatory documentation is required
- Demonstrated technical skillset with analytics and/or process development is preferred
- Demonstrated ability in decision making and problem solving is required
- Demonstrated Quality leadership through partnership in a matrixed-organization is required
- Background in Biologics or Cell Therapy Manufacturing is required
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
- Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment
- Must be able to effectively operate and deliver in a continuously evolving regulatory and operations landscape.
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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