Assoc Director, BI&T Compliance & CSV

Bristol Myers Squibb • Devens, MA

49d • Onsite

About The Position

Bristol Myers Squibb is seeking an Associate Director, BI&T Compliance & CSV to lead the Campus IT Compliance and CSV team. This role involves promoting a safe and compliant environment, managing and developing the team, driving continuous improvement, and ensuring the delivery of critical projects. The position also acts as a liaison between site stakeholders and enterprise/business application teams, manages service providers, and supports the BMS culture. A key aspect of this role is owning the Computer System Validation (CSV) process onsite, providing guidance, and supporting Data Integrity and Quality Risk Management programs. The role also ensures IT compliance support and project execution for GxP business operations, defines and tracks SLAs, collaborates with Digital Plant leaders, and manages the adoption of BMS standard processes and systems. The Associate Director will represent Digital Plant during audits and inspections, maintain GxP-related documents, and ensure compliance with regulatory requirements for IT systems. They will also track project progress, provide management updates, and pursue innovative solutions, including evaluating vendor recommendations and industry trends.

Requirements

• Bachelor’s degree in Engineering, Information Technology, Computer Science, or related field.
• Minimum of 12 years of experience in pharmaceutical quality operations, quality assurance, quality systems, computer system validation, and/or IT compliance roles.
• Proven leadership skills and track record of success in managing regulated IT compliance and validation initiatives.
• Demonstrated leadership skills in coaching, managing, and mentoring staff members, including effective team selection and personnel management.
• Expertise in 21 CFR 210, 211, and 11, and GAMP standards for validation of automated systems is required.
• A high level of understanding and experience in computer system validation and qualification principles is required.
• Knowledge of Quality principles, system development lifecycles, and QA methodologies, such as ISO 9001.
• Experience with IT oversight of electronic systems supporting GMP operations is required.
• Demonstrated ability to work effectively with US FDA and other regulatory agencies.
• Substantial knowledge of QSR, GMP, FDA, GAMP, ISO, ICH, and other applicable standards and guidance regimes.
• Experienced documentation and technical writing skills.
• Excellent technical troubleshooting abilities.
• Demonstrated creative problem-solving skills.
• Ability to lead highly effective teams both at a local site level and across the network.
• Strong collaboration and cross-functional leadership skills to drive continuous improvement, promote knowledge sharing, and implement best practices across the network.

Nice To Haves

• 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.

Responsibilities

• Lead the Campus IT Compliance and CSV team.
• Promote a safe and compliant environment and mindset.
• Select, develop, coach, and manage the Devens Campus IT Compliance and CSV team.
• Set goals, objectives, and contributions of the Campus IT Compliance and CSV team.
• Drive continuous improvement of team productivity and KPIs.
• Ensure the team delivers critical projects on time.
• Act as a liaison between site stakeholders and enterprise/business application teams to ensure business continuity is maintained.
• Manage service providers and ensure alignment with contractual SLAs.
• Engage and support PBRG teams in support of the BMS culture.
• Act as the Computer System Validation (CSV) process owner onsite.
• Provide guidance to Digital Plant and site functional groups on CSV process implementation.
• Participate actively with other groups to analyze and address process deficiencies.
• Support the BMS Data Integrity and Quality Risk Management programs.
• Lead campus-wide IT compliance support and project execution.
• Ensure appropriate support for GxP business operations across the Devens campus.
• Define, implement, and track Service Level Agreements (SLA) for supported business-critical activities.
• Collaborate with Devens Digital Plant leaders to address issues and develop plans to reduce support volumes across the site.
• Manage organizational adoption of BMS standard processes and systems, including ServiceNow, and continuously enhance processes to simplify support requirements.
• Foster business and enterprise partner relationships to ensure a high customer satisfaction rating.
• Represent Digital Plant during internal audits and regulatory inspections.
• Ensure that procedures, guidance documents, and other GxP-related documents are maintained in a high state of compliance and audit readiness.
• Ensure the validation, implementation, and change management of regulated IT systems used across the site are conducted in compliance with applicable regulatory requirements.
• Participate actively with other groups to analyze and address process deficiencies, working collaboratively with peers in Validation, Manufacturing, Engineering, Quality, and Digital Plant.
• Effectively track project progress to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
• Provide updates to management through established tools and project dashboards.
• Pursue innovative solutions.
• Periodically review, specify, and revise regulated IT systems supporting site operations.
• Follow industry trends and innovation, finding new technical solutions to meet evolving business needs.
• Evaluate vendor recommendations and lessons learned from other BMS sites.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director