Sr. Director, External Manufacturing Quality, Cell Therapy
Bristol Myers Squibb
This listing was originally posted on Bristol Myers Squibb's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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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
To define and shape the Quality strategy for global Contract Manufacturing Organizations (CMO) and associated Contract Test Labs (CTLs) management for the Cell Therapy External Manufacturing (ExM) network and to ensure a high level of cGMP compliance and the safety, efficacy, and quality of externally manufactured commercial products. This includes but is not limited to the following areas:
1) CAR T (Cell Banks, Plasmids, Vector, and Drug Product) manufacturing/ testing and evolving Gene Editing technologies for both clinical and commercial products.
2) Areas managed by BMS companies, e.g., 2Seventy Bio (testing) and Orbital Therapeutics (in vivo).
3) Patient Operations as it relates to global Apheresis Centers.
To lead a team of Quality Senior Directors or others in the oversight of the External Manufacturing Network. To build relationships with senior leadership in the CMO and CTL network to support the Virtual Plant Teams (VPTs) and Virtual Analytical Teams (VATs) and to proactively manage and improve CMO Quality performance through risk-based oversight and periodic reviews.
To drive significant impact on current and future business performance through building a functionally excellent infrastructure (knowledge, processes, and systems) to handle moderately complex quality and compliance responsibilities.
Support Development of the Quality Strategy and the Quality Planning for the Cell Therapy External Manufacturing Organization and the Quality Global Business unit.
Owns the strategy of the Cell Therapy External Manufacturing Quality team.
Ensures all aspects of Quality Management of External Supplier/CMO is carried out according to the standards defined and is regularly reported and assessed for adequacy of performance.
Develop a high-performance quality culture with the Cell Therapy Vector and External Manufacturing Operations (VExMQ) organization
Builds strong organizational capability for current and future needs. Recruit and develop global talent to sustain local and global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
Support deployment of operational excellence strategies within VExMQ
Prepare and manage VExMQ organizational budget
Ensures the Quality Assurance Agreements for Suppliers/CMOs are created and maintained according to GMP and requirements, that they are regularly reviewed and followed, and that they address the respective roles, responsibilities and requirements for all parties involved in the supply of the product.
Manage/support the resolution of quality and technical problems in alignment with global standards
Deploys Quality Risk Management Techniques for quality oversight and problem resolution for CMOs to mitigate unacceptable risk in conjunction with BMS Manufacturing/Supply management and Quality.
Support audits and Health Authority inspection for the CMOs as necessary, including the assistance in the generation of HA responses and CAPAs. Ensure that the all-critical and major issues, which may have an adverse effect on the quality of the product, or represent a risk of supply are escalated as per standard procedures to management and are resolved within stated timelines.
Assure appropriate quality governance through performance of management reviews of quality KPIs, metrics, process performance indicators, and quality system signals and ExM CMO supply risks. Initiate corrective actions when necessary and perform follow-up on resulting measures.
Ensure that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS
Provides oversight and resourcing where applicable within the VExMQ organization for projects (transfers, launches, due-diligence, other) – providing support where needed to ensure compliance with the QMS, and to facilitate issues escalation and resolution.
Coordinates and/or provides SME input to for BMS Policies, Directives, SOPs related to quality compliance when required.
Leads communication and develops effective strategies & partnership with stakeholders from MSQ, OPEX, Supply Chain, Regulatory, Project Management, and Operations.
Ensures improved oversight of onboarding and offboarding in the fast changing Life Cycle Management of CT products.
Ability to travel up to 25% (Domestic US and International).
Qualifications
Specific Knowledge, Skills, Abilities:
Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
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 influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders 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 VP Cell Therapy Global Quality and interface with stakeholders in a matrix environment.
Uses judgment to make sound decisions based on information gathered and analyzed.
Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
Sets and maintains high performance standards. Pays close attention to detail, accuracy, and completeness.
Has a proven track record of delivering results and is action oriented.
Adapts to changing work environments, work priorities and organizational needs.
Plans and organizes tasks and work responsibilities to achieve objectives. Sets priorities. Schedules activities.
Education/Experience/ Licenses/Certifications:
Minimum bachelor’s degree in science or pharmaceutical related fields (Chem, Pham, Bio, Chem Eng). Advanced degree preferred.
Mastery of global Quality compliance processes and regulations, e.g., cGMP/GDP regulations for External Manufacturing QA.
A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations.
Thorough understanding of technical areas related to pharmaceutical and/or biological manufacturing, sterility assurance, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes.
>15 years of experience managing Quality and Compliance organizations.
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.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
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.
Supporting People with Disabilities
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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
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: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
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