Training Associate

Training Associate

The LA is accountable for platform-specific curriculum design, development, and maintenance within the GMQLD operating model. The LA partners with site SMEs, Platform Leads, and the COE to ensure training content is current, compliant, and aligned to manufacturing process needs.

Platform Curriculum Design & Development

• Design and develop platform-specific training content within COE governance frameworks and global standards.
• Address 90% platform-level content and 10% site-specific needs, as assigned by the M2/P4 Platform Lead.
• Partner with site Subject Matter Experts (SMEs) on curriculum development, ensuring content reflects current manufacturing processes.
• Apply process-based curricula principles — organize content by manufacturing process with task-level qualification.
• Ensure curriculum aligns to the three-layer content model (Global / Platform / Site).

Content Governance & Quality

• Design content within COE standards, governance frameworks, and compliance requirements.
• Feed content gaps and site needs up to Platform Lead and COE for resolution.
• Pull global content from COE as foundation for platform-specific curriculum.
• Support learning equivalency, exception and substitution decisions in alignment with the Quality system.

Collaboration & Stakeholder Partnership

• Partner with Platform Lead (M2/P4) on L&D strategy and business priorities across platform site
• Interface with COE for standards, governance, and cross-platform alignment.
• Collaborate with LEPs to understand site-specific execution needs and inform curriculum updates.
• Represent the platform in cross-functional forums, audits, and governance reviews.

Continuous Improvement

• Support Time to Qualification optimization initiatives by identifying training burden, content redundancy, and qualification bottlenecks.
• Contribute to OJT standardization across platform sites.
• Use data to identify improvement opportunities in curriculum effectiveness and qualification outcomes.

Basic Qualifications

• Education Level: Bachelor's degree, OR a minimum of 10 years of equivalent relevant experience in lieu of a degree.

Experience

• 5+ years' experience in a GxP-regulated environment.
• Area or functional specific expertise in Learning & Development, instructional design, or Manufacturing/Quality operations.
• Experience with curriculum design, learning management systems, and GMP training requirements.
• Strong understanding of GxP and Good Manufacturing Practices (GMP), regulatory requirements, and compliance training.
• Certifications: N/A
• Licenses: N/A
• Language Requirements: English proficiency (written & verbal)
• Required Skills Testing: N/A

Additional Skills/Preferences

• Deep knowledge of platform-specific manufacturing processes (e.g., PFS, Cartridge, DAP/EM, Chemical, Biologics).
• Experience with process-based or competency-based curriculum architecture.
• Ability to work across multiple sites and time zones.
• Strong collaboration skills with cross-functional teams (Quality, Operations, Engineering).
• Experience with digital learning tools, DOJT, or OJT standardization.
• Familiarity with Workday, SuccessFactors, or equivalent HR/learning systems.