Working with UsChallenging. 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 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: careers.bms.com/working-with-us .At Bristol Myers Squibb we are reimagining the future of cell therapy . With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.The Director, Investigations and Compliance , leads a team of investigators who perform complex, trend deviations within the Quality Management System. The Director will also lead cross functional teams that support Breyanzi and Abecma’s license to operate. They champion continuous improvement activities to exceed investigation and Quality system action metrics, improve product robustness and process understanding, and reduce manufacturing defects. They will also make improvements to the processes for investigations, corrective and preventative actions.Responsibilities:
Provides oversight of lead investigators
In partnership with Quality, executes the investigations and CAPA programs
Establishes and reports metrics for investigations and CAPAs. In collaboration with Quality Assurance, provide oversight of Investigations/CAPA management and tracking to ensure timely and compliant closure
Ensure safe and compliant cGMP operations and maintain permanent inspection readiness to support the manufacturing sites. Actively supports regulatory inspections.
Interact with global and site teams including Process Engineering and Manufacturing Support, Engineering and Facilities, Manufacturing Operations, Quality Assurance, and Quality Control
Stay current with industry trends and BMS standards and participate in best practice forums consistent with function responsibilities.
Hires, integrates and develops high quality talent, capable of delivering against the department goals and objectives
Defines and enforces performance measures, provides developmental feedback and coaching
Create an environment of teamwork, open communication, and a sense of urgency which enhances unit performance and integration across site departments
Support organizational strategic goals and objectives that are linked to the overall company strategy
Champion continuous improvement, problem solving, and incident prevention initiatives
Drive strong collaboration across the Cell Therapy network
Deliver business results through timely and quality decision making and advice
Qualifications & Experience:
Experience in leading investigations, performing root cause analysis and identifying corrective and preventative actions
Experience in building and growing an organization into a high performing team
Excellent verbal/written communication skills and ability to influence at all levels
Ability to think strategically and to translate strategy into actions
Ability to prioritize and provide clear direction to team members in a highly dynamic environment
Experience with Operational Excellence and Lean Manufacturing is a plus.
Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
Experience in cell therapy, biologics, or vaccine manufacturing support, tech transfer, and validation is required.
Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is required
Bachelor’s Degree required (science or engineering is preferred); Graduate or higher-level Degree is preferred
15 or more years of work experience in the biopharmaceutical or related industry
8 or more years of people management experience
The starting compensation for this job is a range from $178,000- $224,000 (if based in Devens, MA) and $182,000-$229,000 (if based in Seattle, WA), 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 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 our BMS Career Site.Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the 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 support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, 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.#LI-HybridBMSCARTVETERANIf 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 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 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 [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility 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.Company: Bristol-Myers SquibbReq Number: R1581705Updated: 2024-05-30 01:19:15.358 UTCLocation: Summit-NJBristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.