Associate Director, Training and Deviations
Bristol Myers Squibb
August 19, 2026
On-site
Summit, NJ
Operations
Shift Available:
- Monday–Friday, Onsite Day Shift, 10 a.m.–6 p.m. (flexibility to support evening team as needed)
Responsibilities:
- Lead a compliant, learning-focused manufacturing training and deviation management function; oversee Manufacturing Trainers and Deviation Assessment Writers.
- Develop and deliver site-specific manufacturing training strategy; ensure audit-ready training documentation.
- Ensure deviation assessments/investigations (and related quality artifacts) are thorough, high-quality, and aligned with GMP, BMS policies, and applicable regulatory requirements.
- Drive Right First Time (RFT): identify training gaps contributing to deviations and implement interventions to reduce recurrence.
- Represent the function in quality councils/review boards (e.g., CCRB, IRB as applicable); support internal/external audits; define improvement strategies.
- Identify and mitigate risks related to workforce competency and deviation trends to protect product quality and safety.
- Participate in/facilitate CAPAs and Change Control from deviation investigations and training effectiveness findings.
- Conduct Quality/Safety Gemba walks to observe operations, identify training gaps, and confirm GMP-aligned, audit-ready practices.
- Ensure coverage and responsiveness across a 24-hour, 365-day operation.
- Use lean principles to improve training/deviation workflows while maintaining validated, compliant processes.
- Manage Training & Deviations OPEX budget; track/report KPIs and project/portfolio performance.
Qualifications / Required Skills:
- Bachelor’s degree in Life Sciences, Biology, Chemistry, Engineering, Pharmacy, or related field (or equivalent education/experience).
- 8+ years relevant manufacturing experience (with degree) or 12+ without.
- 6+ years leadership experience (direct people management).
- 5+ years developing/executing training strategies in regulated manufacturing.
- 5+ years leading deviation investigations and CAPA management.
- Extensive knowledge of EOHSS, cGMP, and ATMP requirements.
- Skilled in deviation assessment, root cause analysis, CAPA development; design and execute site-specific training strategies; embed safety into training and deviation processes; risk identification/mitigation.
Compensation (role-posted):
- Summit West, NJ, US: $156,450–$189,582.
Application instructions:
- Apply through BMS careers site (no further instructions provided in the posting excerpt).
- Monday–Friday, Onsite Day Shift, 10 a.m.–6 p.m. (flexibility to support evening team as needed)
Responsibilities:
- Lead a compliant, learning-focused manufacturing training and deviation management function; oversee Manufacturing Trainers and Deviation Assessment Writers.
- Develop and deliver site-specific manufacturing training strategy; ensure audit-ready training documentation.
- Ensure deviation assessments/investigations (and related quality artifacts) are thorough, high-quality, and aligned with GMP, BMS policies, and applicable regulatory requirements.
- Drive Right First Time (RFT): identify training gaps contributing to deviations and implement interventions to reduce recurrence.
- Represent the function in quality councils/review boards (e.g., CCRB, IRB as applicable); support internal/external audits; define improvement strategies.
- Identify and mitigate risks related to workforce competency and deviation trends to protect product quality and safety.
- Participate in/facilitate CAPAs and Change Control from deviation investigations and training effectiveness findings.
- Conduct Quality/Safety Gemba walks to observe operations, identify training gaps, and confirm GMP-aligned, audit-ready practices.
- Ensure coverage and responsiveness across a 24-hour, 365-day operation.
- Use lean principles to improve training/deviation workflows while maintaining validated, compliant processes.
- Manage Training & Deviations OPEX budget; track/report KPIs and project/portfolio performance.
Qualifications / Required Skills:
- Bachelor’s degree in Life Sciences, Biology, Chemistry, Engineering, Pharmacy, or related field (or equivalent education/experience).
- 8+ years relevant manufacturing experience (with degree) or 12+ without.
- 6+ years leadership experience (direct people management).
- 5+ years developing/executing training strategies in regulated manufacturing.
- 5+ years leading deviation investigations and CAPA management.
- Extensive knowledge of EOHSS, cGMP, and ATMP requirements.
- Skilled in deviation assessment, root cause analysis, CAPA development; design and execute site-specific training strategies; embed safety into training and deviation processes; risk identification/mitigation.
Compensation (role-posted):
- Summit West, NJ, US: $156,450–$189,582.
Application instructions:
- Apply through BMS careers site (no further instructions provided in the posting excerpt).