Associate Director, 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.

Position Summary:

Lead and manage Computer System Assurance (CSA) efforts for systems and applications in core GxP functions – primarily SAP and Data Lake ecosystem. Supervise junior to mid-level team members assigned to IT and Compliance programs to ensure effectiveness, efficiency, consistency, quality of work and compliance with external regulations and internal procedures.

Collaborate with cross functional and multi-location IT Delivery teams, business users and internal Global Quality compliance staff to ensure that CSA activities are planned and executed in accordance with internal procedures. Work with one-up manager and peers to propose effective and efficient quality strategies.

Evaluate, propose, and implement technology solutions that improve digitization, compliance, and productivity. Serve as a CSA 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.

At BMS, digital innovation and Information Technology are central to our vision of transforming patients’ lives through science. To accelerate our ability to serve patients around the world, we must unleash the power of technology.  We are committed to being at the forefront of transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision making, and enhanced patient care. If you want an exciting and rewarding career that is meaningful, consider joining our diverse team!

Desired Candidate Characteristics: 

• Have an exceptional commitment to a career in quality and technology with a passion for healthcare 

• Ability to understand the needs of the business and commitment to deliver the best user experience and adoption 

• Able to collaborate across multiple teams  

• Demonstrated leadership experience

• Excellent communication skills 

• Innovative and inquisitive nature to ask questions, offer bold ideas and challenge the status quo 

• Agility to learn new tools and processes 

Key Responsibilities:

• Functional and Technical:

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

  • Develop and implement validation strategies and plans for processes and systems.

  • Lead validation projects, including the preparation of Validation Plans, Summaries, Testing strategies and review of validation protocols. Identify and assess validation risks and develop mitigation strategies.

  • Ensure all validation activities comply with organization quality standards, regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GxP, ISO).

  • Coordinate with cross-functional teams, including Quality Assurance, Technology Owners, Manufacturing, and IT, 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.

• People Management:

  • Oversees and support CSV staff across defined GxP business unit