Assoc Director, BI&T Compliance & CSV

Duties / 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 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 maintain business continuity. 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 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 maintain a high customer satisfaction rating. Represent Digital Plant during internal audits and regulatory inspections. Ensure procedures, guidance documents, and other GxP‑related documents are maintained in compliance and audit readiness. Ensure validation, implementation, and change management of regulated IT systems are conducted in compliance with regulatory requirements. Analyze and address process deficiencies in collaboration with peers across Validation, Manufacturing, Engineering, Quality, and Digital Plant. Track project progress to 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 to find new technical solutions that meet evolving business needs. Evaluate vendor recommendations and lessons learned from other BMS sites. Requirements Bachelor’s degree in Engineering, Information Technology, Computer Science, or related field, with a 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 a track record of success in managing regulated IT compliance and validation initiatives. Demonstrated leadership skills in coaching, managing, and mentoring staff, including effective team selection and personnel management. Expertise in 21 CFR 210, 211, and 11, and GAMP standards for validation of automated systems; deep understanding of computer system validation and qualification principles. Knowledge of quality principles, system development lifecycles, and QA methodologies such as ISO 9001. Experience with IT oversight of electronic systems supporting GMP operations. 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. Compensation Overview Devens – MA – US: $176,720 – $214,137. Additional incentive cash and stock opportunities may be available based on eligibility. Final compensation will be decided based on demonstrated experience. Benefits Health Coverage: Medical, pharmacy, dental, and vision care. Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well‑being and Protection: 401(k) plan, disability insurance, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Paid Time Off: Unlimited flexible time off for US exempt employees (subject to manager approval) with 11 paid national holidays (excluding Phoenix, AZ, Puerto Rico, or Rayzebio); Phoenix, AZ, Puerto Rico and Rayzebio non‑exempt hourly employees receive 160 hours annual paid vacation plus 11 national holidays and 3 optional holidays. Additional leave options: 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 a Global Shutdown between Christmas and New Years Day. Equal Employment Opportunity: BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support in their roles. BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws. #J-18808-Ljbffr Bristol Myers Squibb EU Policy