WORKING WITH US

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POSITION SUMMARY

The Senior Director, Cell Therapy Global Product Quality Lead ( Sr. Dir. CT- GPQ L ) is accountable for delivering commercially robust and globally compliant quality strategies and outcomes that sustain the product supply chain throughout the product lifecycle . He/She m anage s product quality risk throughout the product lifecycle, including oversight of process and analytical lifecycle , control strategies, comparability, specifications, and stability . The Sr. Director m onitors commercial operations through periodic reviews of process and method performance, including Annual Product Quality Reviews as well as p rovide s general support and leadership within the Global Product Quality organization . The Sr. Director a uthor s designated sections o f regulatory filing s , review s all sections for clarity, technical persuasiveness , consistency and completeness , and serve s as a subject matter expert an d strategist during health authority inspections .
The scope of the role may include one or more cell therapy programs (clinical/commercial) , encompassing the internal and external manufacturing and testing of cell banks, gene delivery materials , drug product intermediates, drug product, and finished labeled drug product. This role will partner with Analytical Sciences and T e chnology , Process and Analytical Development , Manufacturing Sciences and Technologies, Stability , Quality Assurance , Q uality Control , GRS CMC to develop and execute product quality strategies .

KNOWLEDGE AND SKILLS:

The Sr. Dir. CT-GPQL , must be skilled in the development of quality strateg ies with little external guidance, ensuring product quality throughout the lifecycle . The Sr. Dir. CT-GPQL is a motivated, engaged, solutions-driven , strategic , and adaptable leader who supports the ED CTQ GPQ and the senior Cell Therapy Leadership Team, in the advancement of quality readiness. In particula r , the Sr. Dir. CT-GPQL has:

• Expertise in GMP compliance, global regulations, and strong understanding of pharmaceutical product development lifecycle, with specific emphasis on gene delivery and cell therapy preferred.
• Experience authoring, review ing , and representing Quality in support of both clinical and commercial regulatory submissions across multiple domestic and international jurisdictions .
• Demonstrated decision making and problem-solving capabilities relative to Quality, compliance, technical considerations, and regulatory requirements
• Demonstrated Quality leadership through partnership in a matrixed organization is required
• Working background in Biologics, Gene Delivery , or Cell Therapy Manufacturing
• 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 "
• Experience implementing quality strategy and standards
• Direct experience participating in interactions with global regulatory agencies and in the preparation of regulatory submissions
• Demonstrated ability to develop technical and strategic leadership talent to meet current and future business needs
• Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end to end enterprise) and makes the best decisions for the whole
• Excellent influenc e and negotiati on experience and capabilit y in a matrix environment
• A ble to interact with senior leaders from both C ell Therapy Development and Operations and GPS in this capacity and as such is seen as a highly regarded and a credible leader with the ability to act on behalf of the ED of CT Q to interface with stakeholders in a matrix environment
• The ability to anticip ate and effectively influence future trends in the industry.

Professional experience and qualifications:

• Master’s or PhD degree in Biochemistry, Immunology, Molecular Biology, Chemistry, Biology or corresponding e ngineering discipline preferred
• At least 1 2 years of experience in cell therapy, pharmaceutical and/or biotechnology fields in M anufacturing O perations or Quality roles
• Travel : This role requires about 10% travel.

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.

The Senior Director, Cell Therapy Global Product Quality Lead wil l l ead a matrixed team of Product Quality Leaders to :

• Partner across Global Product Quality, Analytical Sciences and Technology, CT D evelopment and O perations, and CT R egulatory CMC to define and deliver product quality strategies that comply with internal and external quality standards and regulatory requirements.
• Provide global product quality oversight of assigned areas of responsibility and support manufacturing operations including developing and maintaining relationships with partner organizations .
• Support the overall Q uality plan based on Cell Therapy Development and Operations annual goals, critical projects, and/or life-cycle support for Product Team objectives , regulatory commitments, and process and product monitoring KPIs.
• Provide quality expertise in accordance with global regulatory requirements and internal policies in support of p roduct c haracterization, p roduct s pecifications, m ethod v alidation, s tability and c omparability assessments for manufacturing and site changes .
• Drive timely and compliant completion of the Annual Product Quality Review ensuring coordination with leads of contributing .
• Perform Quality review of CMC sections of r egulatory submissions and response s. May author CMC sections or responses to queries, as needed .
• R epresent Quality in CMC meetings with global regulatory agencies and during regulatory inspections.
• R epresent Quality o n the CMC and GO-CT teams.
• Act as QA approver for product specifications and product labeling as needed .
• Provide supportive quality oversight and guidance during product launch to program teams .
• Provide strategic guidance and facilitate the timely implementation of manufacturing and testing changes . May own 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 .
• Influence industry and health authorities and ensure staff present at external conferences
• Identify and mentor future leaders