Associate Director, Principal Product Quality Lead - Global Product Quality
Posted on Apr 12, 2021 by Bristol-Myers Squibb
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 new technologies and materials for Quality to meet product goals. The PQL will roll-out product quality frameworks relating to end-to-end Quality management of clinical manufacturing, life-cycle improvements, platform alignments 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 Lead 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 over multiple aspects of the cell therapy program as it moves through clinical development, including regulatory filings and supporting development reports. The individual must be able to appropriately manage and gain input from Quality to inform strategies to align new platform technologies into commercial networks.
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 and Author clinical and commercial regulatory filings as needed.
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 12+ 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
Expertise in product platform alignment and gap analysis across sites is strongly preferred
Experience with review of market applications, IND, supplements or similar regulatory documentation is required
Direct experience with regulatory authorities in the capacity of topic, program, or audit lead is preferred
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