The Associate Director, Training and Deviations, is a leadership role that serves as the cornerstone of a compliant, capable, and continuously evolving manufacturing organization. This role 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. Working in close partnership with the Sr. Director, this role takes a proactive approach to workforce development and quality event management, ensuring that people, processes, and compliance standards at the site level are continuously strengthened.
Given the demands of a 24-hour, 365-day manufacturing operation, this role is critical in ensuring that training readiness and deviation management support are consistently available and responsive across all shifts and operational cycles - leaving no gap in compliance coverage or workforce competency.
In summary, this role exists to ensure the right people have the right knowledge at the right time - and that when things go wrong, the organization learns, adapts, and improves.
Shift Available:- Monday - Friday, Onsite Day Shift, 10 a.m. - 6 p.m. (flexibility to support evening team as needed)
Responsibilities:ValuesLeads 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 - fostering a collaborative environment where learning and operational excellence go hand in hand.
QualityAccountable for the oversight and delivery of the 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. Accountable for the integration and adherence to global quality standards and metrics as they relate to training compliance and deviation management. 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. RFT in the development of robust training materials by proactively assessing the learning needs of the manufacturing organization and providing flexible, audience-centered delivery approaches - ensuring training content is relevant, effective, and impactful the first time it is introduced. Represents the Training and Deviations function in quality councils and associated review boards, including CCRB, IRB, and other applicable forums, as applicable. Supports and leads internal and external audits related to training and deviation management, developing appropriate improvement strategies to maintain operational processes within compliance and licensure guidance. 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. Responsible for setting 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 across the manufacturing organization. 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 directly observe manufacturing operations, identify training gaps, assess deviation trends at the source, and ensure processes and practices remain aligned with GMP standards and audit-readiness expectations.
SafetyAccountable for fostering a strong safety culture within the Training and Deviations function by embedding safety awareness into training programs and deviation assessment processes. Responsible for the integration and maintenance of global EOHSS standards within manufacturing training content owned by the Training and Deviations department. Participates in regular safety Gemba walks with functional area owners and site leadership team members to observe working conditions, identify safety training needs, and drive improvements.
PerformanceAccountable 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 arising within the manufacturing organization. Proactively develops and implements strategies that reinforce a Right First Time culture through effective workforce training and thorough deviation investigations. Accountable for 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 and executing strategies to mitigate impacts on safety, compliance, and organizational performance. Ensures that training and deviation management support is accessible and responsive across a 24-hour, 365-day manufacturing operation - maintaining consistent coverage across all shifts and operational cycles to prevent gaps in compliance, workforce competency, or deviation response.
Continuous Improvement / Lean DeploymentResponsible for identifying and implementing 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, while ensuring all processes remain in a validated and compliant state. Owns and implements lean practices within the Training and Deviations function to streamline processes, eliminate redundancies, and contribute to broader BMS operational objectives. Engages with global and site quality counterparts to facilitate participation in network-wide training and deviation management projects, ensuring site alignment with global standards and best practices. Accountable for reporting performance metrics and goal progress in daily, weekly, and monthly functional and site Tier meetings, including contributions to the site metric control plans. Leads and participates in, and manages multiple complex projects simultaneously, ensuring timely delivery and alignment with site and organizational priorities. Responsible for managing the Training and Deviations project portfolio, ensuring all initiatives progress on schedule and deliver measurable outcomes.
TrainingAccountable for ensuring the proper assignments and current training status of all manufacturing staff, always 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 across both product lines. 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 that address both current and emerging organizational needs.
BudgetsResponsible 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, providing transparent reporting to the Sr. Director and site leadership as required.
Knowledge and Skills: Leadership & People Development- Leads by example, fostering an accountable, engaged, and learning-focused team culture.
Quality & Compliance- Strong working knowledge of GMP regulations and applicable regulatory requirements.
Deviation & Investigation Management- Skilled in deviation assessment, root cause analysis, and CAPA development.
Training Strategy & Instructional Design- Proven ability to design and execute site-specific manufacturing training strategies.
Safety & Risk Management- Embeds safety awareness into training programs and deviation processes.
- Proficient in risk identification, assessment, and mitigation.
Performance & Operational Excellence- Experienced in supporting a 24-hour, 365-day manufacturing operation.
Continuous Improvement & Lean- Manages complex project portfolios and delivers initiatives on time.
Financial Acumen- Tracks and reports budget utilization and project performance transparently.
Communication & Stakeholder Engagement- Communicates clearly and credibly across all organizational levels.
- Demonstrates aptitude for biotechnology principles, Adult Learning Principles, Learning Management Systems, Deviation Writing, Quality Management Systems, and manufacturing systems. Adaptable to a fast paced, complex, and ever-changing business environment. Demonstrated capabilities to implement learning cultures within manufacturing. Excellent communication skills and stakeholder management. Proven track record of strong People Manager capabilities with an aptitude to motivate large teams for the delivery of excellent performance.
Behaviors- Highly organized and disciplined in delivery of exceptional results. Support in the resolution of manufacturing and technical issues while maintaining / meeting compliance requirements. Identify and/or implement agile solutions that lead the organization to higher production, compliance, or safety capabilities. Champions a culture of exceptional teamwork, trust and communication across the organization. Identifying and where possible mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients. Actively engages in the development of direct and indirect colleagues to retain talent within BMS. Able to motivate and influence others to build high-performing teams, remove roadblocks that enable efficiency, build a culture of empowerment, problem solving and embracing challenges. Increases efficiency of work through prioritization. Holds self and others accountable to deliver on time with excellence.
Minimum 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.
