Senior Manager, MSAT Investigations

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.

Bristol Myers Squibb Netherlands

Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands.

The Netherlands is also home to our first European Cell Therapy facility, located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey. Check out this video if you want to know more about it!

The Netherlands has everything it takes to become the medicines hub of Europe, the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site, we are looking to grow our team.

Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer? Join us and be a game changer!

For more information about Bristol Myers Squibb Netherlands, visit us at bms.com/nl or careers.bms.com/nl

Position Summary

The Senior Manager, Investigations, starts as an individual contributor and will become a people leader to leads a team that provides investigations support to the Leiden Cell Therapy Manufacturing Facility when the workload is increasing. The Senior Manager will build a team and establish processes for investigations, corrective and preventative actions, audit readiness, APQR, and product complaints. 

Duties/Responsibilities:

• Providing direct supervision of a team of lead investigators 

• In partnership with Quality Assurance, establishing, maintaining, and executing the investigations, CAPA, and product complaints programs 
• Performing Root Cause Analysis Investigations for complex deviations and trend deviations.

• Establishing and reporting metrics for compliance activities (investigations, CAPAs, training, commitments, etc.) 

• In collaboration with Quality Assurance, providing oversight of Investigations/CAPA management to ensure timely and compliant closure 

• Representing the Site MS&T Investigations team in cross-functional forums 

• Performing review and approval of site and department SOPs 

• Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; Actively supporting regulatory inspections 

• Interacting with other teams including Process Engineering, Manufacturing Operations, Quality Assurance, Supply Chain Operations, Site Engineering, and Quality Control 
• Staying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities. 

Knowledge, Skills, and Abilities 

• Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations 

• 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 

Leadership: 

• Hires, integrates, and develops high quality talent, capable of delivering 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 

• Champions continuous improvement, problem solving, and incident prevention initiatives 

• Drives strong collaboration within the Leiden Cell Therapy Manufacturing Facility and across the network 

• Delivers business results through timely and quality decision making and advice 

EDUCATION AND EXPERIENCE  

• Knowledge 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 10 years’ experience in biopharmaceutical operations with 4+ 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 

• Experience in building and growing an organization into a high performing team 

• Experience with Operational Excellence and Lean Manufacturing is a plus 

• Experience in product complaints and APQRs is a plus 

WORKING CONDITIONS: Position may require working in cleanroom manufacturing environment approximately 15% of the time.  Remainder of work is performed in an office environment. 

Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS.

#LI-Hybrid

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 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.

R1602525 : Senior Manager, MSAT Investigations