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Associate Director, Principal Product Quality Lead, Cell Therapy
3 months ago
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:
SummaryBristol 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.
Key ResponsibilitiesProvide 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 transfersSupports 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 programMay 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 inspectionsMay represent Quality in the Global CMC and Commercialization teamsSupports the Product Specification Committee relating to program specific topics, and other product quality related cross-functional teamsAct as QA approver for product specifications and product labeling Provides supportive quality oversight and guidance during product launchProvide 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 phaseQualifications & ExperienceBS/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 preferredExpertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle are requiredExperience with authoring and review of market applications, IND, supplements or similar regulatory documentation is requiredDemonstrated ability in decision making and problem solving is requiredDemonstrated Quality leadership through partnership in a matrixed-organization is requiredBackground in biologics, viral vector, or cell therapy is requiredDemonstrated ability to work cross-functionally and to develop and maintain strong business partner relationshipsProven 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.#BMSCart, #Veteran, #LI-OnsiteIf 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 scienceTM ", 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 Visit 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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
