Assoc Director, BI&T Compliance & CSV
Bristol Myers Squibb
August 13, 2026
Remote friendly (Devens, MA)
United States
IT
Duties/Responsibilities
- Lead the Campus IT Compliance and CSV team; promote safe/compliant environment; select/develop/coach/manage team; set goals/KPIs; deliver critical projects on time; liaise between site stakeholders and enterprise/application teams; manage service providers/SLAs; support PBRG teams.
- Act as the Computer System Validation (CSV) process owner onsite; guide Digital Plant/site groups on CSV implementation; analyze/address process deficiencies; support Data Integrity and Quality Risk Management programs.
- Lead campus-wide IT compliance support and project execution: ensure GxP support; define/track SLAs; collaborate with Digital Plant leaders to reduce support volumes; drive adoption of BMS standard processes/systems (e.g., ServiceNow) and improve processes; foster partner relationships and customer satisfaction; represent Digital Plant in audits/inspections; maintain GxP documentation compliance/audit readiness; ensure validation/implementation/change management of regulated IT systems comply with regulations; track project progress; provide management updates via tools/dashboards.
- Pursue innovative solutions: review/specify/revise regulated IT systems; follow industry trends; evaluate vendor recommendations.
Requirements
- Bachelor’s degree in Engineering/IT/CS or related; minimum 12 years in pharma quality/QA/systems/CSV and/or IT compliance roles.
- Proven leadership managing regulated IT compliance/validation; coaching/mentoring; strong cross-functional/collaboration skills.
- Expertise in 21 CFR 210, 211, and 11 and GAMP for validation of automated systems; strong understanding of CSV/qualification.
- Knowledge of quality principles, SDLC, ISO 9001; IT oversight of electronic systems supporting GMP.
- Ability to work with US FDA/other regulators; substantial knowledge of QSR/GMP/FDA/GAMP/ISO/ICH.
- Documentation/technical writing; troubleshooting; creative problem-solving; ability to lead local and network-wide teams.
Compensation/Benefits (as stated)
- Devens, MA: $176,720–$214,137; additional incentive cash/stock may be available.
- Health, wellbeing, financial protection, and paid time off.
Application instructions
- If you’re intrigued but don’t perfectly match, encouraged to apply anyway.
- Lead the Campus IT Compliance and CSV team; promote safe/compliant environment; select/develop/coach/manage team; set goals/KPIs; deliver critical projects on time; liaise between site stakeholders and enterprise/application teams; manage service providers/SLAs; support PBRG teams.
- Act as the Computer System Validation (CSV) process owner onsite; guide Digital Plant/site groups on CSV implementation; analyze/address process deficiencies; support Data Integrity and Quality Risk Management programs.
- Lead campus-wide IT compliance support and project execution: ensure GxP support; define/track SLAs; collaborate with Digital Plant leaders to reduce support volumes; drive adoption of BMS standard processes/systems (e.g., ServiceNow) and improve processes; foster partner relationships and customer satisfaction; represent Digital Plant in audits/inspections; maintain GxP documentation compliance/audit readiness; ensure validation/implementation/change management of regulated IT systems comply with regulations; track project progress; provide management updates via tools/dashboards.
- Pursue innovative solutions: review/specify/revise regulated IT systems; follow industry trends; evaluate vendor recommendations.
Requirements
- Bachelor’s degree in Engineering/IT/CS or related; minimum 12 years in pharma quality/QA/systems/CSV and/or IT compliance roles.
- Proven leadership managing regulated IT compliance/validation; coaching/mentoring; strong cross-functional/collaboration skills.
- Expertise in 21 CFR 210, 211, and 11 and GAMP for validation of automated systems; strong understanding of CSV/qualification.
- Knowledge of quality principles, SDLC, ISO 9001; IT oversight of electronic systems supporting GMP.
- Ability to work with US FDA/other regulators; substantial knowledge of QSR/GMP/FDA/GAMP/ISO/ICH.
- Documentation/technical writing; troubleshooting; creative problem-solving; ability to lead local and network-wide teams.
Compensation/Benefits (as stated)
- Devens, MA: $176,720–$214,137; additional incentive cash/stock may be available.
- Health, wellbeing, financial protection, and paid time off.
Application instructions
- If you’re intrigued but don’t perfectly match, encouraged to apply anyway.