Associate Director, Principal Product Quality Lead

Bristol Myers Squibb • Devens, MA

12d • $162,860 - $217,073

About The Position

Bristol-Myers Squibb is seeking an Associate Director, Principal Product Quality Leader (PQL), in Global Product Quality to support commercial projects within the Cell Therapy organization. The PQL will be responsible for overseeing the lifecycle management of a commercial cell therapy product. The PQL will provide direct technical and quality compliance oversight of the commercial program (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 for a commercial program along with associated regulatory expectations 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 commercial manufacturing, life-cycle improvements and control strategies. The PQL is a matrixed leader able to plan for strategic implementation of commercial 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 including analytical and process lifecycle changes, regulatory submissions, and health authority communications.

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 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.

Nice To Haves

• Expertise is Lentiviral Vector manufacturing or analytics with validation experience is a plus.

Responsibilities

• 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 deliverables, technical 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 life-cycle management activities.
• Review clinical and commercial regulatory filings as needed.
• 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.
• Chairs the Analytical Subteam 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 analytical and process protocols and reports, stability protocols and reports.
• Owner of product release and stability specifications and strategy
• 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
• Serves as quality oversight for product and stability trend investigations

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees