Senior Manager, Investigations, Cell Therapy
3 weeks ago
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 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 .
Position: Senior Manager, Investigations, Cell Therapy
Location : Devens, MA facility
(on-site) Monday to Friday 8:00am to 4:30 pm
Key ResponsibilitiesResponsibilities include, but are not limited to, the following:Direct supervision of a team of lead investigatorsIn partnership with Quality Assurance, establishes, maintains, and executes the investigations, CAPA, and product complaints programs.In collaboration with Quality Assurance, provides oversight of Investigations/CAPA management to ensure timely and compliant closure.Facilitates the lead investigator training & certification program.Represents the Site MS&T Investigations team in cross-functional forums & projects.Performs review and approval of site and department SOPs.Maintains permanent inspection readiness; Actively supports regulatory inspections.Interacts with other teams including Manufacturing Operations, Process Support/Engineering, Manufacturing Support, Quality Assurance, Supply Chain Operations, Site Engineering, and Quality ControlStays current with industry trends and BMS standards and participates in best practice forums consistent with function responsibilities.Leadership:Hires, integrates, and develops high quality talent who can deliver against the site & department goals and objectives.Defines and enforces performance measures; provides developmental feedback and coaching.Creates an environment of teamwork, open communication, and a sense of urgency which enhances unit performance and integration across site departments.Supports organizational strategic goals and objectives that are linked to the overall company strategy through analytical & risk-based thinking; Makes recommendations and implements actions to meet strategic goals & objectives.Drives the development of efficient, consistent processes, and builds a workplace culture of continuous improvement through strong problem solving/creative skills.Identifies and recommends improvements to the organization, processes, procedures, and the Quality Management System.Delivers business results through timely, quality, and risk-based decision making and advice.Qualifications & ExperienceKnowledge of science generally attained through studies resulting in a bachelor's degree in science, engineering, biochemistry or related discipline, or its equivalent is required.A minimum of 8 years' experience in biopharmaceutical operations with 2+ years of prior management experience required.Experience leading investigations, performing root cause analysis, and identifying corrective and preventative actions required.Experience in cell therapy, biologics, or vaccine manufacturing/support required.Proficient in cGMPs and multi-national biopharmaceutical/cell therapy regulationsExcellent verbal and written communication skills to allow effective interactions with all levels of the organization and with a work style that is decisive yet approachable.Strong priority-setting skills, with exceptional attention to detail and the ability to work on multiple projects at the same time.Experience in building and growing an organization into a high performing team.Ability to think strategically and to translate strategy into actions.Experience with Operational Excellence/Six Sigma and Lean Manufacturing is a plus.Experience in product complaints and APQRs is a plus.#BMSCART #LI-Onsite #VETERAN
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.
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 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 Protocol
BMS 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 adastaffingsupport@bms.com . Visit careers.bms.com/ 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.
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