Associate Director, IT Quality Services
Bristol Myers Squibb
2 months ago
Remote friendly (Princeton, NJ)
United States
IT
Position Summary
- Lead and manage Computer System Assurance (CSA) and IT qualification efforts for systems and applications in core GxP functions (primarily Research, Commercial, Cell Therapy).
- Supervise junior to mid-level team members to ensure effectiveness, efficiency, consistency, quality, and compliance with external regulations and internal procedures.
- Collaborate with cross-functional, multi-location IT Delivery teams, business users, and Global Quality compliance to plan/execute CSA per internal procedures and develop quality strategies.
- Evaluate, propose, and implement AI-based technology solutions to improve digitization, compliance, and productivity.
- Act as CSA subject-matter-expert for regulatory inspections; collaborate on quality, data integrity, and computer system validation procedures.
Key Responsibilities (Functional/Technical)
- Develop/implement validation strategies and plans; lead validation projects (Validation Plans/Summaries/testing strategies/protocol reviews).
- Identify/assess validation risks and mitigation strategies.
- Ensure validation activities comply with quality standards, regulations (e.g., FDA/EMA), and industry standards (GxP/ISO).
- Coordinate with QA, Technology Owners, Manufacturing, and IT; provide training/guidance.
- Support internal/external audits and continuously improve validation methods.
People Management
- Oversee/support CSV staff to ensure systems are “fit for use” before release to production.
- Supervise employees/contractors; train/mentor junior staff.
Qualifications & Experience
- 12–15+ years in IT Compliance/CSV in pharma; 5+ years managing/overseeing IT Compliance and CSV projects.
- Mandatory knowledge: CSA; 21 CFR Part 11; EU Annex 11; Data Integrity; GAMP; Agile.
- 3–5 years planning/implementing validation strategies across GxP ecosystems.
- Highly preferable: ServiceNow, ALM, Veeva.
- Mandatory: Pharma GxP IT testing practices/tools (e.g., ALM).
- Strong leadership, communication, written presentation skills; decision-making with minimal supervision; openness to learning.
Benefits (as listed)
- Health coverage; wellbeing support; financial wellbeing/protection (e.g., 401(k), disability, life insurance); paid time off.
Application instructions
- Apply even if your resume doesn’t perfectly match; you may be close to a role that fits.
- Lead and manage Computer System Assurance (CSA) and IT qualification efforts for systems and applications in core GxP functions (primarily Research, Commercial, Cell Therapy).
- Supervise junior to mid-level team members to ensure effectiveness, efficiency, consistency, quality, and compliance with external regulations and internal procedures.
- Collaborate with cross-functional, multi-location IT Delivery teams, business users, and Global Quality compliance to plan/execute CSA per internal procedures and develop quality strategies.
- Evaluate, propose, and implement AI-based technology solutions to improve digitization, compliance, and productivity.
- Act as CSA subject-matter-expert for regulatory inspections; collaborate on quality, data integrity, and computer system validation procedures.
Key Responsibilities (Functional/Technical)
- Develop/implement validation strategies and plans; lead validation projects (Validation Plans/Summaries/testing strategies/protocol reviews).
- Identify/assess validation risks and mitigation strategies.
- Ensure validation activities comply with quality standards, regulations (e.g., FDA/EMA), and industry standards (GxP/ISO).
- Coordinate with QA, Technology Owners, Manufacturing, and IT; provide training/guidance.
- Support internal/external audits and continuously improve validation methods.
People Management
- Oversee/support CSV staff to ensure systems are “fit for use” before release to production.
- Supervise employees/contractors; train/mentor junior staff.
Qualifications & Experience
- 12–15+ years in IT Compliance/CSV in pharma; 5+ years managing/overseeing IT Compliance and CSV projects.
- Mandatory knowledge: CSA; 21 CFR Part 11; EU Annex 11; Data Integrity; GAMP; Agile.
- 3–5 years planning/implementing validation strategies across GxP ecosystems.
- Highly preferable: ServiceNow, ALM, Veeva.
- Mandatory: Pharma GxP IT testing practices/tools (e.g., ALM).
- Strong leadership, communication, written presentation skills; decision-making with minimal supervision; openness to learning.
Benefits (as listed)
- Health coverage; wellbeing support; financial wellbeing/protection (e.g., 401(k), disability, life insurance); paid time off.
Application instructions
- Apply even if your resume doesn’t perfectly match; you may be close to a role that fits.