Executive Director, Cell Therapy Global Product Quality
Executive Director, Cell Therapy Global Product Quality
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 260860 - 316096
1 Vacancy
Job Description
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: 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 $260860- $316096 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 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 -life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility/infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
If you come across a role that intrigues you but doesnt 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 Careers
With a single vision as inspiring as Transforming patients lives through science 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 a supportive culture promoting global participation 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 Protocol
BMS has an 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.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Exec
Employment Type
Full-Time
