Manager, IT Quality Services

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.

Summary:

Lead and manage Computer System Validation (CSV)/Computer System Assurance (CSA) and qualification efforts for systems used across multiple functional business organizations supporting regulated processes. Engage with project team for CSV projects ensuring efficiency, consistency, quality of work and compliance with external regulations and internal procedures. Collaborate with IT Delivery teams, business users and internal business functions staff to ensure that CSV activities are planned and executed in accordance with internal procedures. Work with one-up manager and peers to propose effective and efficient quality strategies for IT implementation across multiple business functions. Refine and standardize SDLC and CSV processes for continuous improvement. Serve as a CSV subject-matter-expert in support of internal and external regulatory inspections. Collaborate with peers across BMS on procedures relating to quality, data integrity and computer system validation.

Responsibilities:

• Execute CSV /CSA activities for IT capabilities ensuring technology systems are designed and fit for their intended use in accordance with industry best practices and regulatory requirements.

• Perform Regulatory Risk Assessments, creates Validation Plans, Validation Summary Reports, Co-ordinate Data Integrity Assessments for various IT implementations

• Collaborate with business and IT representatives to understand business needs, challenges, and opportunities and how CSA can be leveraged to deliver value.  Translates those needs to efficient validation and testing strategies.

• Ensures adherence to software development practices, compliance, and key IT controls

• Coordinate with cross-functional teams, including Quality Assurance, Technology Owners, Business Owners to ensure successful validation outcomes.

• Provide training and guidance to team members and stakeholders on validation processes and best practices.

• Participate in internal and external audits and inspections, providing validation-related support and documentation.

• Continuously improve validation processes and methodologies to enhance efficiency and compliance.

• Responsible for training and mentoring junior staff to meet BMS quality standards.

• Ability to coach teams across functions on GxP processes, IT controls as well as ITSM processes

Skills & Requirements:

• B.S. or equivalent in computer science, engineering, life science or related field preferred.  

• A minimum of 5-8 years’ experience in core computer systems validation in the pharmaceutical industry (development of CSV deliverables, execution of software testing, data integrity concepts), including at least 2+ years managing CSV projects.

• Candidate must be a subject matter expert in computer system validation, GAMP, Electronic Records/Electronic Signature regulations, and related health authority regulations and guidelines.

• Knowledge of SAP Platforms and Technologies, AWS Big Data Platforms and Clinical functions is preferred.

• Candidate must be technically conversant in concepts and techniques related to software development and data management.

• Demonstrated ability to plan and organize effectively across multiple projects and tasks.

• Demonstrated ability to influence, collaborate, and communicate directly at various organizational levels.

• Strong oral and written communication skills including the ability to write superior documentation and deliver clear and articulated presentations.

• Open to creative, innovative, flexible and practical approaches to improving practices and solving problems. 

• Experience in Agile software development methodologies. 

• Preferred experience with working in a multi-cultural, multi-location and diverse environments

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.

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/

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