The Director of Organizational Learning & Development is responsible for designing, implementing, and overseeing the company’s enterprise-wide training and development strategy to ensure employees across R&D, Manufacturing, Quality, Regulatory Affairs, and Commercial functions have the knowledge and skills to perform safely, compliantly, and effectively.
Responsibilities
- Develop and execute a comprehensive training strategy aligned with business goals, regulatory requirements, and organizational growth.
- Establish training KPIs/metrics to measure program effectiveness, compliance rates, and business impact.
- Lead onboarding, technical/scientific, leadership development, and soft-skills training program design.
- Develop SOPs/work instructions related to training processes.
- Collaborate with SMEs across Manufacturing, QC/QA, R&D, and Regulatory to create role-specific training content.
- Evaluate and implement innovative training methodologies (e-learning, simulation, hands-on/practical, VR for cleanroom/lab procedures).
- Design and deliver GxP training (GMP, GLP, GCP, GDP) to ensure FDA/EMA and global compliance.
- Identify capability, engagement, career development, and team effectiveness needs and prioritize improvements.
- Ensure role-based curriculum completion and manage compliance tracking in the LMS.
- Support CAPA investigations related to training gaps/deviations.
- Manage relationships with external training vendors/consultants/certification bodies and training platforms.
- Act as primary point of contact for training inquiries during internal audits and regulatory inspections.
- Continuously assess training needs via gap analyses, employee feedback, and audit findings; benchmark industry best practices.
Key Competencies
- Strategic thinking with hands-on execution; regulatory/compliance acumen; leadership/team development; cross-functional collaboration; project/organizational skills; adaptability.
Requirements
- Bachelor’s degree in Life Sciences, Education, Organizational Development, Human Resources, or related field.
- 8+ years training and development experience; 3–5+ years in a leadership role in biotech/pharma/medical devices.
- Excellent instructional design, facilitation, and communication skills.
- Strong knowledge of GxP (GMP, GLP, GCP) and FDA/EMA compliance.
- Experience with enterprise training programs and LMS platforms (e.g., Veeva Vault Training, Cornerstone, SuccessFactors).
- Track record leading teams and managing cross-functional stakeholders.
- Experience supporting regulatory inspections/audits from a training compliance perspective.
Preferred
- Master’s or PhD.
- Certifications in instructional design (CPTD/ATD) or quality systems (ASQ CQA).
- Experience in manufacturing/GMP environment; adult learning theory/competency-based models; training analytics tools.
Benefits/Pay/Application
- Wisconsin pay range: $190,000–$230,000; California pay range: $210,000–$250,000.
- Arrowhead provides competitive salaries and an excellent benefit package.
- Candidates must have current, valid authorization to work in the country where this role is located.