Associate Director, IT Quality Services
Bristol Myers Squibb
2 months ago
Remote friendly (New Brunswick, NJ)
United States
IT
Position Summary
- Lead and manage Computer System Assurance (CSA) and IT qualification efforts for GxP systems/applications (Research, Commercial, Cell Therapy).
- Supervise junior–mid level IT/Compliance team members; ensure effectiveness, quality, and compliance with external regulations and internal procedures.
- Collaborate with cross-functional/multi-location IT Delivery teams and Global Quality compliance to plan/execute CSA activities; propose 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.
Key Responsibilities
- Translate business needs into qualification/validation/testing strategies.
- Develop validation strategies/plans; lead validation projects (plans, summaries, testing strategies, protocol review).
- Identify/assess validation risks and develop mitigations.
- Ensure validation compliance with FDA/EMA and industry standards (GxP, ISO); coordinate with QA, Technology Owners, Manufacturing, and IT.
- Train stakeholders; support internal/external audits and continuously improve validation methods.
People Management
- Oversee/support CSV staff across GxP applications; supervise employees/contractors; train/mentor junior staff; coach GxP, IT controls, ITSM.
Qualifications & Experience
- 12–15 years in pharma IT Compliance/CSV (min. 5 years leading/overseeing IT Compliance/CSV projects).
- Working knowledge of CSA, 21 CFR Part 11, EU Annex 11, data integrity, GAMP, Agile; pharma validation strategy experience (3–5 years).
- Preferred: ServiceNow, ALM, Veeva (2–3 years).
- IT testing knowledge; understanding of IT systems (SaaS/IaaS, networks, OS, databases).
Benefits (as stated)
- Health coverage (medical/pharmacy/dental/vision), wellbeing programs, 401(k), disability/life insurance; paid time off (flexible time off or annual vacation depending on location).
- Lead and manage Computer System Assurance (CSA) and IT qualification efforts for GxP systems/applications (Research, Commercial, Cell Therapy).
- Supervise junior–mid level IT/Compliance team members; ensure effectiveness, quality, and compliance with external regulations and internal procedures.
- Collaborate with cross-functional/multi-location IT Delivery teams and Global Quality compliance to plan/execute CSA activities; propose 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.
Key Responsibilities
- Translate business needs into qualification/validation/testing strategies.
- Develop validation strategies/plans; lead validation projects (plans, summaries, testing strategies, protocol review).
- Identify/assess validation risks and develop mitigations.
- Ensure validation compliance with FDA/EMA and industry standards (GxP, ISO); coordinate with QA, Technology Owners, Manufacturing, and IT.
- Train stakeholders; support internal/external audits and continuously improve validation methods.
People Management
- Oversee/support CSV staff across GxP applications; supervise employees/contractors; train/mentor junior staff; coach GxP, IT controls, ITSM.
Qualifications & Experience
- 12–15 years in pharma IT Compliance/CSV (min. 5 years leading/overseeing IT Compliance/CSV projects).
- Working knowledge of CSA, 21 CFR Part 11, EU Annex 11, data integrity, GAMP, Agile; pharma validation strategy experience (3–5 years).
- Preferred: ServiceNow, ALM, Veeva (2–3 years).
- IT testing knowledge; understanding of IT systems (SaaS/IaaS, networks, OS, databases).
Benefits (as stated)
- Health coverage (medical/pharmacy/dental/vision), wellbeing programs, 401(k), disability/life insurance; paid time off (flexible time off or annual vacation depending on location).