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

Role Summary

Senior Manager, GxP Strategic Training Partner (STP) for CMC, serving as a dedicated strategic partner to assigned operational or functional business areas. Responsible for translating business needs and regulatory expectations into effective, practical, and inspection-ready learning solutions. Operating within the STP model led by the Associate Director, GxP Training & Learning Strategy, STPs are experts in adult learning who diagnose needs, challenge assumptions, and design learning approaches that improve execution—not just training completion. The STP shapes learning approaches that support business outcomes, regulatory compliance, and inspection readiness, partnering closely with Quality, Operations, and documentation teams. This hybrid role can be worked as Hybrid (up to two days remote) or On-Site with ad hoc flexibility.

Responsibilities

• 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, and 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.

Qualifications

• Required: 5+ years of experience designing and supporting GxP learning solutions in regulated environments.
• Required: Demonstrated expertise in adult learning theory, instructional design, and performance consultation.
• Required: Proven ability to partner with operational and Quality stakeholders and translate needs into actionable solutions.
• Required: Strong understanding of GxP regulations and inspection expectations related to training.
• Required: Experience working with LMS platforms and regulated training systems (Cornerstone, Veeva preferred).
• Required: Strong project and stakeholder management skills.
• Preferred: Experience operating as a learning business partner or strategic partner.
• Preferred: Demonstrated ability to deeply understand a specific operational or functional area.
• Preferred: Experience supporting multiple modalities within the pharmaceutical industry (Small Molecule, Cell & Gene Therapy, Medical Devices).
• Preferred: Direct experience working in and supporting learning solutions for outsourced manufacturing environments.
• Preferred: Ability to balance standardization with business-specific needs.
• Preferred: Comfortable challenging assumptions while maintaining strong partnerships.

Education

• Bachelor’s degree in Instructional Design, Education, Life Sciences, or related field; Master’s degree preferred.