Senior Manager, GxP Strategic Training Partner , CMC (contract) 121212

The Senior Manager, GxP Strategic Training Partner (STP) serves 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.

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

Key Responsibilities

Strategic Business Partnership

• Act as the primary training and learning partner for assigned business areas, developing a strong understanding of:
  o Core processes and workflows
  o Operational risks and pain points
  o 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:
  o Align on priorities and expectations
  o Escalate risks or misalignment
  o 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 in a business partner or strategic partner model.
• Demonstrated ability to deeply understand and support a specific operational or functional area.
• Experience supporting multiple modalities (Small Molecule, Cell & Gene Therapy, Devices).
• Experience working in or supporting outsourced manufacturing environments.
• Ability to balance standardization with business-specific needs.
• Comfortable challenging assumptions while maintaining strong partnerships.

$75-$80/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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