Bristol Myers Squibb
Product Quality Lead - Early Development
Bristol Myers Squibb, Summit, New Jersey, us, 07902
Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Position Summary:Bristol-Myers Squibb is seeking a Product Quality Leader (PQL), Associate Director of Global Product Quality to support early development projects within the Cell Therapy Development Organization. The PQL will be responsible to oversee programs through clinical implementation through pivotal. The PQL will provide direct technical and quality compliance oversight of early stage development programs (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations in support of the program.
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.
Key Responsibilities:
Provides 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.Reviews clinical and commercial regulatory filings as needed.Develops and refine the Guidance for product quality requirements along the development continuum.Demonstrates the ability to influence others through persuasive interactions and garner support for novel solutions where applicable.Shows 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.Assists in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase.Qualifications & Experience:
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 Lentiviral Vector manufacturing or analytics with validation experience is a plus.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 Vaccines, 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.
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Position Summary:Bristol-Myers Squibb is seeking a Product Quality Leader (PQL), Associate Director of Global Product Quality to support early development projects within the Cell Therapy Development Organization. The PQL will be responsible to oversee programs through clinical implementation through pivotal. The PQL will provide direct technical and quality compliance oversight of early stage development programs (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations in support of the program.
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.
Key Responsibilities:
Provides 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.Reviews clinical and commercial regulatory filings as needed.Develops and refine the Guidance for product quality requirements along the development continuum.Demonstrates the ability to influence others through persuasive interactions and garner support for novel solutions where applicable.Shows 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.Assists in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase.Qualifications & Experience:
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 Lentiviral Vector manufacturing or analytics with validation experience is a plus.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 Vaccines, 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.
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