Associate Director, Strategy and Services, Enterprise Quality Systems

Posted:
8/20/2024, 5:00:00 PM

Location(s):
New Brunswick, New Jersey, United States ⋅ New Jersey, United States

Experience Level(s):
Senior

Field(s):
Business & Strategy

Workplace Type:
Hybrid

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.

The Associate Director, Strategy and Services, in the Global Product Development and Supply (GPS) Enterprise Quality Systems organization will be working to maintain, enhance, and ensure operation readiness as well as compliance for both non-GxP and GxP instrument connected/embedded computer hardware, software, as well as site and global applications used by the GPS and Global Quality (GQ) organizations.   This position requires a passion for IT, Compliance, and Operational Excellence.  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

  • Lead/Main Contributor to the strategy, direction and implementation of Global Laboratory Systems and Benchtop Computer Strategy and Services.
  • Lead, co-lead, or act as a subject matter expert on global projects with a focus on standardization of business processes, technical upgrades, or tools
  • 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 technical work assignments as a point of contact for project stakeholders.
  • Lead or provide supporting activities within the quality management system.
  • 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 subject matter expertise 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.
  • Assist and contribute to financial planning within the group and to identify saving opportunities.
  • Complies with all Computer System Validation requirements and regulations.

Qualifications & Experience

  • BS degree in life sciences, engineering, or computer science field or equivalent experience.
  • 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.
  • 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.

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 [email protected]. 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.

Bristol Myers Squibb

Website: https://bms.com/

Headquarter Location: New York, New York, United States

Employee Count: 10001+

Year Founded: 1887

IPO Status: Public

Last Funding Type: Post-IPO Debt

Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine