Associate Director, Principal Product Quality Lead, Cell Therapy
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.
Bristol Myers Squibb is seeking an Associate Director, Principal Product Leader within the Cell Therapy Global Product Quality organization. The Principal PQL will support the Global Product Quality Lead (PQL) by providing supportive quality oversight of the assigned program from late clinical development phase through commercialization / launch and entire lifecycle. The Principal PQL assists the Global PQL to develop and implement global product quality strategies relating to manufacturing, development, control strategies, stability, product complaints, etc. to minimize product quality risks during product development, technology transfer, and commercial operations. The Principal PQL supports efforts to establish collaborations between Regulatory Affairs, Process Development, MS&T, Analytical Development, Site Quality (QA/QC) and Internal/External Operations to ensure regulatory compliance of GMP operations in support of the assigned program. This role can be stationed either in Seattle, WA, Summit NJ or Devens, MA and reports to the Global Product Quality Leader, Cell Therapies.
- Provide global product quality oversight over assigned areas of responsibility and support manufacturing operations including developing and maintaining relationships with other QA, QC, development, analytical, manufacturing sciences and technology, and regulatory functions.
- Supports the overall product quality plan based on Product Development Team objectives, regulatory commitments, and process and product monitoring KPIs as directed by the Global PQL.
- Assists and may provide quality expertise in accordance with global regulatory requirements and internal policies in the creation of product characterization, product specifications, method validation, stability and comparability assessments for tech transfers
- Supports Global Annual Product Quality Review deliverables (as required) that may include coordinating with leads of contributing chapters and ensure timely and compliant execution of the program
- May act as author or Quality reviewer of CMC sections of regulatory submissions and response to global agencies queries; may author CMC sections or responses to queries, as needed.
- May represent Global Product Quality in CMC meetings with global regulatory agencies and during regulatory inspections
- May represent Quality in the Global CMC and Commercialization teams
- Supports the Product Specification Committee relating to program specific topics, and other product quality related cross-functional teams
- Act as QA approver for product specifications and product labeling
- Provides supportive quality oversight and guidance during product launch
- Provide strategic guidance and facilitate the timely implementation of global changes with respect to the assigned product. 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
Qualifications and Education Requirements
- BS/MS in relevant science or engineering discipline and 7+ years of experience in a relevant discipline in a pharmaceutical or bio-pharmaceutical organization; 1-3 years of experience in a PQL role is preferred
- Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle are required
- Experience with authoring and review of market applications, IND, supplements or similar regulatory documentation is required
- Demonstrated ability in decision making and problem solving is required
- Demonstrated Quality leadership through partnership in a matrixed-organization is required
- Background in biologics, viral vector, or cell therapy 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.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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