Associate Director Training and Deviations - Summit West, NJ

This role is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers.

About the role

This leadership role serves as the cornerstone of a compliant, capable, and continuously evolving manufacturing organization. The Associate Director, Training and Deviations is accountable for shaping and delivering a site-specific manufacturing training strategy while ensuring the consistent production of thorough, high-quality deviation assessments and investigations that safeguard product quality and regulatory compliance.

As an integral member of the Process Improvement and Compliance Team, this leader directly oversees two specialized teams — Manufacturing Trainers and Deviation Assessment Writers — uniting their efforts to drive a culture of learning, accountability, and operational excellence across both product lines. The role ensures that training readiness and deviation management support are consistently available and responsive across all shifts and operational cycles in a 24-hour, 365-day manufacturing operation.

Responsibilities

• Values:
  • Leads by example, modeling BMS values and holding their team accountable to the same standards of integrity, inclusion, and excellence.
  • Builds and sustains an engaging, accountable, and learning-focused team culture that inspires continuous growth and high performance across the Training and Deviation Assessment teams.
  • Actively supports the manufacturing operational team by ensuring they are equipped with the knowledge, competencies, and resources needed to perform at their best.
• Quality:
  • Oversees and delivers site-specific manufacturing training programs and deviation assessments, ensuring alignment with GMP regulations, BMS policies, and all applicable regulatory requirements.
  • Ensures training documentation, deviation records, and associated quality artifacts are always maintained in a consistently audit-ready state.
  • Drives Right First Time (RFT) principles within the manufacturing organization by identifying training gaps that contribute to deviations and implementing targeted interventions to reduce recurrence.
  • Represents the Training and Deviations function in quality councils and review boards, including CCRB, IRB, and other applicable forums.
  • Supports and leads internal and external audits related to training and deviation management, developing improvement strategies to maintain compliance.
  • Identifies, assesses, and prioritizes risks related to workforce competency and deviation trends, implementing proactive strategies to mitigate their impact on compliance, product quality, and safety.
  • Sets the strategic direction for the Training and Deviations function, ensuring alignment with site and global compliance, budgetary, safety, and technical requirements.
  • Provides compliant, practical solutions to training and deviation-related challenges, supporting continuous improvement programs.
  • Participates in, facilitates, and drives meaningful CAPAs and Change Control implementation arising from deviation investigations and training effectiveness findings.
  • Conducts regular Quality Gemba walks with functional area owners to observe manufacturing operations, identify training gaps, and assess deviation trends.
• Safety:
  • Fosters a strong safety culture within the Training and Deviations function by embedding safety awareness into training programs and deviation assessment processes.
  • Integrates and maintains global EOHSS standards within manufacturing training content.
  • Participates in regular safety Gemba walks with functional area owners and site leadership to observe working conditions and identify safety training needs.
• Performance:
  • Accountable for the quality and compliance of all training records and deviation assessments produced by the Training and Deviations team.
  • Serves as the primary point of contact for escalated training compliance issues and major deviation investigations.
  • Proactively develops and implements strategies that reinforce a Right First Time culture through effective workforce training and thorough deviation investigations.
  • Ensures adherence to Training and Deviations performance KPIs, including training completion rates, deviation closure timelines, and repeat deviation rates.
  • Identifies, assesses, and prioritizes potential risks associated with workforce competency and deviation trends, developing strategies to mitigate impacts on safety, compliance, and performance.
  • Ensures training and deviation management support is accessible and responsive across a 24-hour, 365-day manufacturing operation.
• Continuous Improvement / Lean Deployment:
  • Identifies and implements training and deviation process improvements that contribute to BMS and site-level goals.
  • Applies lean principles to drive efficiency and reduce waste within training delivery and deviation investigation workflows.
  • Owns and implements lean practices within the Training and Deviations function to streamline processes and eliminate redundancies.
  • Engages with global and site quality counterparts to facilitate participation in network-wide training and deviation management projects.
  • Reports performance metrics and goal progress in daily, weekly, and monthly functional and site Tier meetings.
  • Leads and manages multiple complex projects simultaneously, ensuring timely delivery and alignment with site and organizational priorities.
• Training:
  • Ensures the proper assignments and current training status of all manufacturing staff, maintaining compliance with site and regulatory training requirements.
  • Accountable for the site manufacturing technical training program, including the timely onboarding and qualification of new staff to manufacturing operations.
  • Actively identifies training opportunities to optimize compliance, technical knowledge, operational efficiency, and time-to-competency across the manufacturing workforce.
  • Proactively collaborates with the Training & Learning Organization (TLO) to develop, introduce, and continuously improve training programs.
• Budgets:
  • Responsible for maintaining and managing the Training and Deviations operational (OPEX) budget, ensuring resources are allocated effectively to meet functional and site objectives.
  • Implements and owns metrics to monitor and track budget utilization, project progress, and functional performance.

Requirements

• Bachelor's degree in Life Sciences, Biology, Chemistry, Engineering, Pharmacy, or a related scientific field required. An equivalent combination of education and relevant experience may be considered.
• Minimum of 8 years of relevant manufacturing experience with a bachelor's degree, or 12 years of progressively responsible manufacturing experience without a bachelor's degree.
• Minimum of 6 years of leadership experience, including direct management of people leaders.
• Minimum of 5 years of experience developing and executing training strategies within a regulated manufacturing environment.
• Minimum of 5 years of experience leading deviation investigations and CAPA management activities.
• Extensive knowledge of EOHSS, cGMP, and ATMP requirements, with demonstrated ability to lead and operate effectively within a highly regulated manufacturing environment.

Working Conditions

• Primarily office-based with the requirement to work in regulated manufacturing areas, including environments where handling of human blood products (Biosafety Level 2) or exposure to vapor phase liquid nitrogen may occur.
• Must be available and willing to work nights, weekends, and across a shift structure to support a 24-hour, 365-day manufacturing operation.
• May be required to perform aseptic gowning in accordance with site and GMP standards when entering manufacturing areas.

Schedule

Monday - Friday, Onsite Day Shift, 10 a.m. - 6 p.m. (flexibility to support evening team as needed).

Pay

$156,450 - $189,582 per year (Summit West, NJ).