Director, Organizational Learning & Development

The Position

The Director of Organizational Learning & Development is responsible for designing, implementing, and overseeing the company's enterprise-wide training and development strategy. This role ensures employees across R&D, Manufacturing, Quality, Regulatory Affairs, and Commercial functions are equipped with the knowledge and skills needed to perform their roles safely, compliantly, and effectively. The Director will partner closely with senior leadership, Quality Assurance, and Regulatory teams to build a culture of continuous learning that supports GxP compliance, operational excellence, and organizational growth.

This is a full-time, on-site position that may be based in Pasadena, CA or Verona, WI.

Responsibilities

Strategic Leadership

• Develop and execute a comprehensive training strategy aligned with business goals, regulatory requirements, and organizational growth plans.
• Establish training KPIs and metrics to measure program effectiveness, compliance rates, and business impact.

Program Design & Development

• Lead the design of onboarding, technical/scientific, leadership development, and soft-skills training programs.
• Develop standard operating procedures (SOPs) and work instructions related to training processes.
• Collaborate with subject matter experts (SMEs) across departments (Manufacturing, QC/QA, R&D, Regulatory) to create accurate, role-specific training content.
• Evaluate and implement innovative training methodologies (e-learning, simulation, hands-on/practical training, virtual reality for cleanroom/lab procedures, etc.).

Regulatory & Compliance Training

• Collaborate with Quality team on design and delivery of GxP training programs (GMP, GLP, GCP, GDP) to ensure compliance with FDA, EMA, and other global regulatory requirements.
• Partner with Quality, Compliance & Regulatory leadership to identify capability, engagement, career development, and team effectiveness needs and prioritize targeted improvement opportunities.
• Work with leaders throughout the organization to identify required training for various roles as part of new employee onboarding.
• Ensure timely completion of role-based training curricula and manage training compliance tracking within the Learning Management System (LMS).
• Support CAPA (Corrective and Preventive Action) investigations related to training gaps or deviations.

Team & Stakeholder Management

• Manage relationships with external training vendors, consultants, and certification bodies.
• Act as the primary point of contact for training-related inquiries during internal audits and regulatory inspections.
• Manage external vendors, contractors, or platforms used to develop training content (i.e.., Articulate 360)

Systems & Continuous Improvement

• Continuously assess training needs through gap analyses, employee feedback, and audit findings.
• Benchmark against industry best practices to keep programs current with evolving biotech/pharma standards.

Key Competencies

• Strategic thinking with hands-on execution capability
• Strong regulatory and compliance acumen
• Leadership and team development
• Cross-functional collaboration
• Project management and organizational skills
• Adaptability in a fast-paced, evolving industry

Requirements

• Bachelor's degree in Life Sciences, Education, Organizational Development, Human Resources, or related field.
• 8+ years of experience in training and development, with at least 3–5 years in a leadership role within biotech, pharmaceutical, or medical device industries.
• Excellent instructional design, facilitation, and communication skills.
• Strong working knowledge of GxP regulations (GMP, GLP, GCP) and FDA/EMA compliance requirements.
• Demonstrated experience designing and managing enterprise-wide training programs and LMS platforms (e.g., Veeva Vault Training, Cornerstone, SuccessFactors).
• Proven track record of leading teams and managing cross-functional stakeholder relationships.
• Experience supporting regulatory inspections/audits from a training compliance perspective.

Preferred

• Master's Degree or PhD degree in a relevant field.
• Certification in instructional design (e.g., CPTD, ATD certification) or quality systems (e.g., ASQ CQA).
• Experience in a manufacturing/GMP production environment.
• Familiarity with adult learning theory and competency-based training models.
• Experience with data analytics tools for training effectiveness reporting.