Job Description

Working with Us
Challenging. 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. 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

The Executive Director, Cell Therapy Global Product Quality (CTGPQ) is responsible for development and implementation of all quality and compliance life cycle strategies for development, clinical and marketed cell therapy products including cell therapy cell banks, plasmids, vector, intermediates, and drug product.

The Head of CTGPQ manages oversight of strategic Quality initiatives across both early and late-stage development and commercial programs and works in partnership with cross-functional matrix teams including Process Development, Analytical Development, Global Manufacturing Sciences and Technology Operations, Portfolio Management, site and above site QA and QC, Internal and External Manufacturing, Regulatory Affairs and Brand teams. The individual provides end-to-end global quality oversight of all cell therapy development programs for vector and drug product, from First in Human through commercialization, and supports development teams, including comprehensive input into strategy during all global clinical and commercial regulatory filings. This position leads a team to develop life-cycle strategies to proactively minimize product quality risks during product development, technology transfer, commercialization and launch activities in support of all end-to-end Quality strategies for cell banks, plasmids, vector, drug product intermediates, and drug product up through patient administration as required. The role enables efficient communication and decision making related to the Quality aspects of the cell therapy program across the product teams, manufacturing sites and global cell therapy functions.

This position is responsible to lead the Quality Product Lead organization and is the primary point of Quality contact for designated cell therapy products within the BMS network. This role plans and ensures execution of the Quality components of the Product Strategic Plan including, but not limited to: Global Change Control Strategies, Annual Product Quality Reviews, Product Life Cycle initiatives, Product Robustness Plans, and Product Risk Registers. Additionally, the Quality Product Leads are accountable for ensuring robust and consistent filing and inspection readiness for line extensions and other major changes; serves as the escalation coordination point on behalf of Cell Therapy Quality for challenges to meet Global Supply requirements for all CT brands; and is responsible for networking across the internal and external cell therapy Quality organization to reach compliant solutions.

Key Responsibilities

This position partners with Cell Therapy Development and Operations organizations and matrix teams through aligned annual objectives and defined roles and responsibilities:

• Leads a team of Quality Product Leaders with responsibility for cell therapy products and clinical pipeline assets.

• Develops and ensures effective implementation of quality lifecycle strategies for cell therapy commercial, clinical and development products.

• Acts as lead Quality management reviewer/approver of regulatory submissions and responses to global agencies queries.

• Represents Global Product Quality at Cell Therapy Development and Operations forums and governance committees.

• Develops robust communication and tracking tools to enable efficient and effective decision-making and work processes.

• Partners and collaborates with cross-functional leadership (e.g., Development, MS&T, SC, Manufacturing, GRS) to advance the end-to-end product oversight model to ensure robust and compliant supply strategies.

• Assures and assigns singular and effective Quality focal points for cell therapy products serving as members of matrix teams (i.e., GO CT).

• Responsible for ensuring coordination and generation of End-To-End Annual Product Quality Review reports to assure a global view for marketed key brands and advancement of a sustainable process.

• Responsible for optimization of end-to-end supply chain quality strategy for marketed products in conjunction with key stakeholders.

• Responsible for product quality metrics across cell therapy products.

• Ensures evaluation of impact of proposed process changes on the end-to-end supply chain and development of implementation strategies / plans.

• Ensures adequate resources to serve as single points of contact for product-related changes, and Regulatory CMC liaisons responsible for coordinating reviews of regulatory submissions and responses to Health Authority inquiries.

• Responsible to partner with Development to develop robust processes for effective and efficient knowledge transfer of early pipeline assets as the product lifecycle approaches Long Term Stability and Process Validation.

• Responsible to ensure Process Validation, Launch and Pre-Approval Inspection readiness as late-stage pipeline products approach BLA/MAA submission.

• Engaged member of the Governances (e.g., applicable GO-Teams, end-to-end Product Robustness teams) for cell therapy products.

• Owns the global product change management implementation planning processes, end-to-end annual product quality review processes, and end-to-end inspection and launch readiness and supply continuity planning.

Qualifications & Experience

Specific Knowledge, Skills & Abilities:

• Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle are required.

• Experience with review of commercial and clinical market applications, supplements or similar regulatory documentation is required.

• Demonstrated decision making and problem-solving capabilities relative to Quality, compliance, technical considerations, and regulatory requirements are required.

• Demonstrated influential leadership expertise and experience with senior level interactions and influence with Technical, Development, Quality and Compliance, Supply Chain and Regulatory functions.

• Demonstrated people management experience.

• Capability to build alignment amidst diverse perspectives with business partners including research and development, operations, and supply chain at a regional and site level.

• Experience in Cell Therapy (preferred), Biologics and Sterile manufacturing or technical support.

• Strong and demonstrated strategic thinking capability with strong project management focus and ability to focus on execution of strategic decisions while balance conflicting priorities.

• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.

• Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk.

• Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.

• Ability to provide innovative ideas and risk-based alternatives that create value including seeking new information and external insights without compromising compliance.

Education, Experience, Licenses & Certifications:

• Advanced degree in life sciences, manufacturing or related discipline preferred.

• Minimum of 15 years of quality experience for biopharmaceuticals in both R&D and commercial manufacturing environments. Cell therapy experience preferred.

Travel:

• This position requires travel.

The starting compensation for this jobis a range from $260,860- $316,096, 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 where the job is performed.

Final, individual compensation will be decidedbased on demonstratedexperience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit

Benefitofferingsare subject to the terms and conditions of the applicable plans then in effectand may include the following: Medical, pharmacy, dental and vision care. Wellbeing supportsuch asthe 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 ]]> <

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