Responsibilities:
- Develop and execute enterprise training strategy aligned with business goals, regulatory requirements, and growth plans.
- Establish training KPIs/metrics to measure effectiveness, compliance, and business impact.
- Lead onboarding, technical/scientific, leadership, and soft-skills program design.
- Create training SOPs/work instructions; partner with SMEs to build role-specific content.
- Evaluate and implement innovative training methods (e-learning, simulation, hands-on, virtual reality for lab/cleanroom procedures).
- Collaborate with Quality to design/deliver GxP training (GMP/GLP/GCP/GDP) for FDA/EMA and global compliance.
- Identify capability/career/team effectiveness needs and prioritize improvements.
- Ensure timely completion of role-based curricula; manage training compliance via LMS.
- Support CAPA investigations related to training gaps/deviations.
- Manage external training vendors/consultants/certification bodies and training platforms.
- Serve as primary training contact during internal audits/regulatory inspections.
- Conduct gap analyses using feedback/audit findings; benchmark industry best practices.
Requirements:
- Bachelorโs degree in Life Sciences, Education, Organizational Development, Human Resources, or related.
- 8+ years training & development experience; 3โ5 years in a leadership role in biotech/pharma/medical devices.
- Strong instructional design, facilitation, and communication.
- Working knowledge of GxP (GMP/GLP/GCP) and FDA/EMA compliance.
- Enterprise training program and LMS experience (e.g., Veeva Vault Training, Cornerstone, SuccessFactors).
- Team leadership, cross-functional stakeholder management.
- Experience supporting regulatory inspections/audits from a training compliance perspective.
Preferred:
- Masterโs or PhD.
- Instructional design (e.g., CPTD/ATD) or quality systems certification (e.g., ASQ CQA).
- Manufacturing/GMP environment experience; adult learning/competency-based training familiarity; training effectiveness analytics.
Pay/Location:
- On-site; Pasadena, CA or Verona, WI. Wisconsin: $190,000โ$230,000; California: $210,000โ$250,000.
Application instruction:
- Candidates must have current, valid authorization to work in the roleโs country.