Product Quality Lead - Early Development

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.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. Read more: careers.bms.com/working-with-us .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. T he 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 d evelop 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.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 phaseQualifications & 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 is 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.The starting compensation for this job in Seattle, WA is a range from $ 166,000-$208,000 , plus incentive cash and stock opportunities (based on eligibility).The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed.Final, individual compensation will be decided based on demonstrated experience.Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers site: https://careers.bms.comBenefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.