Learning Architect

Learning Architect (LA)

The Learning Architect (LA) is responsible for platform-specific curriculum design, development, and ongoing maintenance within the GMQLD operating model. This role partners closely with site Subject Matter Experts (SMEs), Platform Leads, and the Center of Excellence (COE) to ensure learning content remains current, compliant, and aligned with manufacturing processes and business needs.

The ideal candidate brings a strong combination of Learning & Development/instructional design expertise and experience within a GxP-regulated manufacturing environment.

Key Responsibilities

Platform Curriculum Design & Development

• Design and develop platform-specific training content within COE governance frameworks and global standards.
• Address approximately 90% platform-level content and 10% site-specific content, as assigned by the M2/P4 Platform Lead.
• Partner with site SMEs to develop curricula that accurately reflect current manufacturing processes.
• Apply process-based curriculum principles, organizing learning content by manufacturing process with task-level qualifications.
• Ensure curricula align with the three-layer content model: Global, Platform, and Site.
• Leverage global COE content as the foundation for platform-specific curriculum development.

Content Governance & Quality

• Develop and maintain training content in accordance with COE standards, governance frameworks, quality requirements, and regulatory expectations.
• Identify content gaps and site-specific needs and escalate them to the Platform Lead and COE for resolution.
• Support learning equivalency, exception, and substitution decisions in alignment with the Quality system.
• Ensure learning materials remain current, accurate, compliant, and aligned with manufacturing requirements.

Collaboration & Stakeholder Partnership

• Partner with the Platform Lead (M2/P4) on Learning & Development strategy and business priorities across platform sites.
• Interface with the COE to ensure alignment with global standards, governance requirements, and cross-platform initiatives.
• Collaborate with Learning Execution Partners (LEPs) to understand site-specific execution needs and incorporate feedback into curriculum updates.
• Work cross-functionally with teams including Quality, Operations, Engineering, and Manufacturing.
• Represent the platform in cross-functional forums, audits, and governance reviews.
• Collaborate effectively across multiple sites and time zones.

Continuous Improvement

• Support Time to Qualification optimization initiatives by identifying training burden, content redundancies, and qualification bottlenecks.
• Contribute to On-the-Job Training (OJT) standardization across platform sites.
• Use data and qualification outcomes to identify opportunities to improve curriculum effectiveness.
• Recommend enhancements to learning content, processes, and qualification programs.

Basic Qualifications

Education

• Bachelor's degree required; OR
• Minimum of 10 years of equivalent relevant experience in lieu of a degree.

Experience

• 5+ years of experience in a GxP-regulated environment.
• Experience in one or more of the following areas:
• Learning & Development
• Instructional Design
• Manufacturing Operations
• Quality Operations
• Experience with curriculum design, Learning Management Systems (LMS), and GMP training requirements.
• Strong understanding of:
• GxP requirements
• Good Manufacturing Practices (GMP)
• Regulatory requirements
• Compliance training
• English proficiency, both written and verbal.

Preferred Skills & Experience

• Deep knowledge of manufacturing processes such as:
• Prefilled Syringes (PFS)
• Cartridge manufacturing
• DAP/EM
• Chemical manufacturing
• Biologics
• Experience developing process-based or competency-based curriculum architectures.
• Experience supporting learning programs across multiple manufacturing sites.
• Strong cross-functional collaboration skills, particularly with Quality, Operations, Engineering, and Manufacturing teams.
• Experience with digital learning tools and methodologies.
• Experience with Digital OJT (DOJT), OJT programs, or OJT standardization.
• Familiarity with Workday, SuccessFactors, or similar HR/Learning Management Systems.
• Strong analytical skills with the ability to use data to evaluate training effectiveness and qualification.