Job Description

Role Summary:

The Strategic Training Partner serves as a Workforce Capability Architect for the global QMS, responsible for designing how processes are translated into role-based capabilities, qualifications, and training programs across all quality value streams.

This role partners with Quality System Owners, Process Architects, and Digital Quality Systems to ensure that:

• training reflects true process execution
• capabilities are role-based and risk-based
• training is fully integrated with documentation, systems, and change management

This role requires expertise incapability design and architecture.

What You Will Own:

Process-to-Capability Architecture

Translate process design into role-based capability models by:

• Converting value streams and process maps into:
  • role definitions
  • required competencies
  • capability frameworks
• Definitions of what people must be able to do, not just what they must read
• Ensure alignment between:
  • process steps
  • system interactions
  • required skills

Global Training & Qualification Framework

Define and implement risk-based training that qualifies colleagues to perform GxP processes within a regulated environment.

• Role-based training models
• Curriculum design standards
• Qualification and requalification strategies
• Risk-based training approaches (not one-size-fits-all)

Ensure global consistency across:

• sites
• functions
• modalities

Training Integration Across Value Streams

Ensure training is embedded within end-to-end value streams by:

• Aligning training with:
  • Quality Event & CAPA
  • Change Control
  • Supplier Quality
  • Documentation updates
• Ensure training is triggered by:
  • process changes
  • SOP updates
  • system changes
  • defined business requirements

Holistically assess training content to prevent:

• training that is disconnected from executable tasks or regulatory requirements
• redundant or low-value training

Training Effectiveness & Capability Assurance

Move beyond training completion to true capability assurance by:

• Defining how training effectiveness is measured:
  • performance outcomes
  • error reduction
  • CAPA actions
• Identifying capability gaps through:
  • deviation trends
  • audit findings
  • inspection observations
• Establishing feedback loops between:
  • performance data
  • training improvements
  • KPI outputs

​Digital Alignment (LMS / QMS Integration)

Ensure training is digitally enabled and integrated by:

• Aligning training models with LMS and QMS systems
• Ensuring correct training triggers from:
  • document updates
  • change control
  • CAPA actions
  • business requirements
• Supporting automation of:
  • training assignments
  • on-the-job training recertifications
  • qualification tracking

Change Impact & Synchronization

Define how training evolves with system changes & ensure training updates are synchronized with:

• documentation
• process changes
• system updates

Define impact assessment models for:

• new processes
• updated procedures

Prevent misalignment between:

• what is written
• what is trained
• what is executed

Inspection Readiness & Regulatory Alignment

Ensure training and qualification meet expectations aligned to

ICH Q10 Pharmaceutical Quality System by ensuring GxP training is:

• role-based
• traceable
• inspection-ready
• Supports inspection preparation and responses
• Demonstrates that personnel are qualified, not just trained

Continuous Improvement of Workforce Capability

Drive evolution of how the organization builds capability by introducing and refining modern learning approaches:

• role-based learning
• just-in-time training
• risk-based curricula
• Reduction of unnecessary training burden
• Assessments for workforce effectiveness and personnel performance

Role Requirements:

• 8–12+ years in GxP Quality, Training, or Learning & Development
• Bachelor’s degree in Instructional Design, Education, Life Sciences, or related field; Master’s degree preferred.
• Experience designing global training and qualification frameworks
• Strong understanding of QMS processes and regulatory expectations
• Experience with LMS platforms (e.g., Cornerstone, SuccessFactors)
• Experience with process mapping / value streams preferred
• Ability to translate process requirements into capability models
• Strong stakeholder influence in global, matrixed environments

Pay Range:

$129,400 - $194,200

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid