Working with Us
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.
Summary
The Sr. Director, Quality Technical Operations, Cell Therapy Manufacturing is responsible for leading the day-to-day quality review and approval of investigations, CAPA, Change Controls with associated documents and the oversight of the Quality Engineering team responsible for qualifications and validations of computerized systems, software, enterprise systems, equipment, methods, and manufacturing processes. The Sr. Director, Quality Technical Operations will serve as a primary delegate and proxy for the Head of Quality, Cell Therapy Manufacturing at Summit, and is as a champion for quality principles and compliance within the organization.
Duties and Responsibilities
Responsible for QA oversight of cGMP operations deviations, CAPAs, Change Controls, and qualification/validation at the Summit, NJ Cell Therapy manufacturing facility (S12). Drives for operational adherence to applicable cGMP regulations, BMS policies and procedures.
Provides direction to Operations, Facilities, QC, and QA teams for planned and unplanned deviations to resolve compliance issues and procedural errors, ensuring immediate containment actions are taken, assisting investigators on deviation strategy and documentation, reviewing and approving deviations, supporting identification of appropriate CAPA, and supporting site awareness / retraining following any events.
Strategically identifies, implements, and leads site-wide QA transformational programs and strategies in close partnership with Quality Systems, MS&T, Operations, Supply Chain and Quality Control to reduce Deviations, improve right first time, improve Quality record timeliness, identify and remediate trends, improve turnaround time (TAT), and prevent issues before they occur.
Ensures timely Quality support and approval of GMP documentation, risk assessments and change control impact assessments.
Ensures the required processes, procedures, systems, and resources are in place to enable a compliant manufacturing of CAR T products.
Maintains a comprehensive understanding of S12 manufacturing, QC testing processes and the associated risk management control strategy to identify process risks and associated critical controls around the associated processing steps.
Effectively partners with Manufacturing leadership to enhance technical knowledge of operators and shop floor through timely, positive, and constructive feedback and training.
Serves as primary Delegate of Authority (DOA) and proxy for the Head of Quality, Cell Therapy Manufacturing, Summit, NJ.
Acts as subject matter expert for GMP operations during audits and regulatory inspections. Contributes to the development and execution of the S12 inspection readiness plan. Supports and facilitates Health Authority interactions, and ensures any regulatory observations are adequately addressed and completed on time.
Works together with the S12 Quality Leadership Team to deploy a strategy that fosters a rich team culture, enhances employee satisfaction and retention, and drives a high-performing team.
Provides leadership and builds an exceptional team to manage QA functions, including hiring, mentoring, and developing personnel.
Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the Summit S12 facility
Establishes and effectively manages the Summit Cell Therapy QA Technical Operations annual operating budget.
Specific Knowledge, Skills, Abilities:
Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
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 mindset) 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 as such is seen as a highly regarded and a credible leader with the ability to interface with stakeholders in a matrix environment.
Proven track record of delivering results and is action oriented.
Adapts to changing work environments, work priorities and organizational needs.
Leads within the broader internal and external network and seeks to have impact on organization-wide performance.
Embraces complexity but strives for simplicity.
Shares resources and makes difficult trade-offs to benefit the organization at large.
Creates a vision for the future by spotting strategic opportunities for breakthrough performance.
Translates the case for change into actionable and strategic plans for the organization.
Education/Experience/ Licenses/Certifications:
Bachelor’s degree in relevant Science or Engineering discipline and 15+ years of experience in managing Quality Assurance function; at minimum 7 years of people management experience.
Expertise in Good Manufacturing Practices (GMP) as related to Pharmaceutical, Biotech and/or ATMP Manufacturing.
Experience with implementing and overseeing GMP operations in a plant manufacturing clinical and commercial products is required
Background in Biologics or Cell Therapy Manufacturing is preferred
Demonstrated experience building and leading exceptional teams is required
Demonstrated excellence in written and verbal communication
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
Expert-level expertise in one or more of the following: Pharmaceutical Quality Management, Project Management and/or Lean Six Sigma strongly preferred
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.
Strong presentation and visual management capability required.
Knowledge of performance measurement tools and metrics is required.
Good facilitation, change management, interpersonal and problem-solving skills required.
Experience with management of large teams, including direct and indirect reports, strongly preferred.
Travel: This position requires up to 10% of 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.
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
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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.
R1599623 : Head of QA Technical Operations