Associate Director, IT Quality Services

Bristol Myers Squibb • Princeton, NJ

5d

About The Position

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. Position Summary: Lead and manage Computer System Assurance (CSA) and IT qualification efforts for systems and applications in core GxP functions – primarily Research, Commercial and Cell Therapy functions. 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 AI based 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 with good foundation in latest AI driven technology landscape 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

Requirements

• A minimum of 12-15 years of experience in IT Compliance and computer systems validation (CSV) in the pharmaceutical industry, including at least 5 years of managing/overseeing IT Compliance and CSV projects
• Good understanding (mandatory) of Computer Software Assurance (CSA), 21 CFR Part 11, EU Annex 11, Data Integrity principles, GAMP methodologies and Agile methodologies
• A minimum of 3-5 years of experience in planning and implementing validation strategies across GxP ecosystems and preferable experience in Pharmaceutical Research and Manufacturing domains.
• 2-3 years of experience in using tools like ServiceNow, ALM and Veeva platforms (highly preferable)
• General knowledge of IT applications, IT infrastructure, architecture of computer systems including SaaS, IaaS as well as networks, operating systems, databases, and software tools
• Good knowledge (mandatory) of IT testing practices and methodologies in the Pharma GxP space-and good working knowledge of tools like ALM etc.
• Ability to make decisions that impact own work and other groups/teams and works under minimal supervision
• Demonstrates openness to learning and developing. Takes a responsibility for their own and team’s development and growth.
• Written communication skills, including the ability to deliver clear and articulate presentations.

Responsibilities

• 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 qualification, 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.
• Oversees and support CSV staff across defined GxP business unit applications to ensure 'fit for use' before release to production environment.
• Supervises CSV staff that includes a mix of employees and contractors.
• 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
• Preferred experience with working in a multi-cultural, multi-location and diverse environments

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed