Assoc Director, BI&T Compliance & CSV
Job in
Springfield, Hampden County, Massachusetts, 01119, USA
Listed on 2026-06-28
Listing for:
B.M.S.
Full Time
position Listed on 2026-06-28
Job specializations:
-
Management
IT Project Manager, Regulatory Compliance Specialist
Job Description & How to Apply Below
Role Overview
Lead the Campus IT Compliance and CSV team, promoting a safe and compliant environment and mindset. Select, develop, coach, and manage the team. Drive continuous improvement of team productivity and KPIs.
What You Will DoManage service providers, ensure alignment with contractual SLAs, and act as a liaison between site stakeholders and enterprise/business application teams. Provide guidance to Digital Plant and site functional groups on CSV process implementation.
Why It Might Be a FitProven leadership skills and track record of success in managing regulated IT compliance and validation initiatives. Demonstrated ability to work effectively with US FDA and other regulatory agencies.
Requirements- Bachelor’s degree in Engineering, Information Technology, Computer Science, or related field
- 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
- Expertise in 21 CFR 210, 211, and 11, and GAMP standards for validation of automated systems
- Knowledge of Quality principles, system development life cycles, 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
- 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, survivor support
- Paid Time Off:
Flexible time off (unlimited, with manager approval), 11 paid national holidays, 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays, 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 - Annual Global Shutdown between Christmas and New Years Day
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