Senior Manager, GxP Strategic Training Partner, CMC (Hybrid)

Job Description

This role operates as part of a Strategic Training Partner (STP) model led by the Associate Director, GxP Training & Learning Strategy. STPs are expected to be experts in adult learning and deeply knowledgeable in the business areas they support, enabling them to diagnose needs, challenge assumptions, and design learning approaches that improve execution—not just training completion.

The STP is accountable for shaping learning approaches that support business outcomes, regulatory compliance, and inspection readiness, while partnering closely with Quality, Operations, and documentation teams

Strategic Business Partnership

• Act as the primary training and learning partner for assigned business areas, developing a strong understanding of:
  • Core processes and workflows
  • Operational risks and pain points
  • Regulatory and inspection expectations
• Engage business leaders to understand why training is being requested, what problem is being solved, and what success looks like.
• Challenge and refine training requests to ensure solutions address the right need, not just the requested format.

Learning Strategy & Solution Design

• Conduct learning and performance needs analyses to determine the most effective learning approach, which may include training, performance support, or non-training solutions.
• Design learning solutions grounded in adult learning principles, focusing on relevance, application, and transfer to the job.
• Develop learning architectures and pathways aligned to business and regulatory requirements, including onboarding, role transitions, and critical task readiness.
• Ensure learning solutions are practical, scalable, and aligned with inspection expectations.

Regulatory Alignment & Inspection Readiness

• Ensure learning materials and approaches appropriately reflect GxP requirements and risk.
• Partner with Quality, Document Control, and business SMEs to support inspection-ready training records and evidence.
• Apply risk-based judgment to determine appropriate rigor and documentation.
• Support audits and inspections related to training for assigned business areas.

Execution & Accountability

• Translate agreed learning strategies into clear plans, deliverables, and timelines.
• Manage delivery of learning initiatives, coordinating with training developers, LMS administrators, and documentation teams as needed.
• Evaluate learning effectiveness using appropriate qualitative and quantitative measures.
• Identify opportunities to improve learning impact, efficiency, and sustainability.

STP Model & Team Alignment

• Operate as part of the broader STP community, aligning ways of working, standards, and practices across supported areas.
• Partner closely with the Associate Director, GxP Training & Learning Strategy to:
  • Align on priorities and expectations
  • Escalate risks or misalignment
  • Identify capability gaps or resourcing needs
• Continuously build and maintain expertise in both adult learning practices and the supported business area.

Required Qualifications

• Bachelor’s degree in Instructional Design, Education, Life Sciences, or related field; Master’s degree preferred.
• 5+ years of experience designing and supporting GxP learning solutions in regulated environments.
• Demonstrated expertise in adult learning theory, instructional design, and performance consultation.
• Proven ability to partner with operational and Quality stakeholders and translate needs into actionable solutions.
• Strong understanding of GxP regulations and inspection expectations related to training.
• Experience working with LMS platforms and regulated training systems (Cornerstone, Veeva preferred).
• Strong project and stakeholder management skills.

Preferred Skills & Experience

• Experience operating as a learning business partner or strategic partner.
• Demonstrated ability to deeply understand a specific operational or functional area.
• Experience supporting multiple modalities within the pharmaceutical industry (Small Molecule, Cell & Gene Therapy, Medical Devices).
• Direct experience working in and supporting learning solutions for outsourced manufacturing environments.
• Ability to balance standardization with business-specific needs.
• Comfortable challenging assumptions while maintaining strong partnerships.

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:

1. Hybrid and work remotely up to two days per week; or select

2. On-Site and work 5 days per week with ad hoc flexibility.  

#LI-AR1  #LI-Hybrid

Pay Range:

Disclosure Statement:

Flex Designation:

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
 

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]