Manager, Digital Quality and Governance

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 .

Functional and Technical

• QA review and approval of validation deliverables associated with various BMS enterprise systems, including but not limited to clinical study databases, electronic Case Report Forms (eCRFs), enterprise commercial manufacturing systems such as electronic laboratory notebooks and manufacturing execution systems, ERP systems including SAP and Oracle, Veeva-based systems such as Clinical Trial Management Systems (CTMS), electronic Trial Master File (eTMF), Regulatory Information Management (RIM), and Quality Management Systems (QMS), as well as various Veeva Vault-based configurations.
• Ensure adequate and timely quality assurance / regulatory compliance support
• Provide support during regulatory agency and third party inspections
• Research new technologies, understand existing processes, and reference recognized standards and frameworks
• Pursue continuous professional development through company paid internal / external training, certifications and / or continuing education.
• Identify opportunities for continuous improvement
• Adherence to BMS Core Behaviors
• Conduct risk & impact assessment to determine the extent of validation and qualification and ensure right sized validation effort for programs
• Demonstrate critical thinking around interpreting business and industry challenges and recommending best practices-based solutions to improve products, processes, systems
• Implement organizational IT controls in accordance with applicable regulations and the ability to evaluate and understand the impact of new regulations and requirements
• Review Periodic Review assignments completions for applications in a timely manner
• Support responses to application CAPAs and Audits as they relate to health authority investigations and internal audits in a timely manner-in coordination with multiple stakeholder teams

Qualifications & Experience

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.

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 [HIDDEN TEXT] . 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.

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 /

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Skills Required

Networks, Alm, Agile Methodologies, Saas, Iaas, It Compliance, Databases, 21 Cfr Part 11, Operating Systems, Software Tools, Quality Assurance, Gamp