Job Details
Manager, IT Laboratory and Quality Systems
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 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 Summary
The Manager, IT Laboratory and Quality Systems, in the Devens Digital Plant organization will be working to support, enhance, and maintain compliance for the GxP benchtop instrumentation as well as site and global applications used within the quality, manufacturing, and quality control organizations. This position requires a passion for IT and compliance. Project management and business analyst skillsets would be valuable within the role as the position requires the ability to work with diverse cross-functional teams in a highly matrix organization.
Key Responsibilities
Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as; ViCell, SoloVPE, Cary60, and Spectramax plate readers throughout the Devens biologics campus that includes laboratory and manufacturing buildings.
Support administration of quality and laboratory applications including their software development life cycle activities and technical support.
Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems.
Execute and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure.
Execute and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
Lead or provide supporting activities within the quality management system (Infinity).
Liaison with global partners and internal site departments within BMS to align on solutions, implementation plans, and support structure for benchtop instrumentation and configurations.
Provide local administrative support and liaison with global partners for completing tasks such as application periodic reviews, user access reviews, and account administration.
Provide digital plant subject matter expertise (SME) to multi-function teams and advise operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies.
Ensure alignment with BMS directives and industry guidelines for applications.
Execute on technology improvements and efficiency opportunities to improve business and compliance.
Provide on-call support, as needed, for 24/7 commercial operations.
Qualifications & Experience
BS degree in life sciences, engineering, or computer science field or equivalent experience preferred.
Minimum of 5+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting.
Comprehensive knowledge of GxP compliance, Software Development Life Cycle, and Good Documentation Practices.
Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
Demonstrated leadership skills and the ability to negotiate in a complex environment.
Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications.
Excellent verbal and written communication skills.
The ability to plan and lead small and medium size projects and enhancements.
The candidate needs to be self-driven and capable of prioritizing.
The candidate should have an expanding understanding of network, databases, servers, and PCs.
Understanding of administration and usage of with Waters’ Empower and/or Waters NuGenesis, LIMS (e.g., SampleManager), Infinity, Acronis and emerging technology is preferred.
Developed system application and business analyst skills.
Ability to apply lean and OpEx principles.
Project management, communication, and technical writing skills are required.
The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.
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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 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.