GxP Training Specialist

POSITION SUMMARY

The GxP Training Specialist strengthens business performance by building compliant, scalable learning systems that improve workforce readiness, execution quality, and inspection preparedness across Empower’s hyper-growth 503A and 503B operations. This individual contributor owns the design, deployment, governance, and continuous improvement of role-based GxP curricula, training matrices, learning records, onboarding, and performance support. Partnering with Quality, Operations, and subject matter experts, the role translates complex requirements into capability-building solutions. AI is used as a force multiplier to accelerate content development, expand personalization and scale, improve quality, and enable faster, evidence-based decisions while maintaining human oversight and data integrity. Success requires: strategic thinking, disciplined execution, learning agility, judgment, and the ability to deliver measurable results amid rapid change, regulatory complexity, and elevated standards for patient safety and operational excellence.

RESPONSIBILITIES

Learning Strategy

• Curriculum Architecture: Own the architecture of role-based GxP curricula, qualification pathways, and training matrices across regulated functions, ensuring content aligns with cGMP expectations, standard operating procedures, process risks, and business priorities. Use AI-assisted analysis to identify redundancies, dependencies, and coverage gaps, then convert insights into sequenced learning journeys that accelerate proficiency, support scale, and strengthen inspection readiness without compromising human review, data integrity, or controlled-document governance during rapid organizational growth and change.

• Needs Analysis: Partner with Quality, Operations, Pharmacy, Engineering, and subject matter experts to diagnose performance gaps, distinguish training needs from process or system issues, and define measurable learning outcomes. Apply AI-enabled data synthesis to evaluate deviations, audit observations, learner feedback, and operational trends, enabling faster prioritization and sharper decisions. Translate findings into targeted interventions that improve capability, reduce recurring errors, and focus resources on the highest-risk business needs across sites and functions.

• Program Roadmaps: Develop and maintain training roadmaps that connect onboarding, qualification, role progression, and continuing education to Empower’s growth plans and regulated operating model. Balance urgent deployment needs with sustainable capability building, sequencing initiatives by compliance risk, operational impact, and learner readiness. Use AI-supported scenario planning and forecasting to anticipate demand, evaluate tradeoffs, and scale high-quality learning programs across evolving 503A and 503B environments, enabling consistent standards across teams, shifts, and sites.

Training Execution

• Content Development: Design, develop, and continuously improve instructor-led, virtual, digital, and performance-support content using adult learning principles, instructional design models, and controlled-document requirements. Use approved AI tools to accelerate drafting, generate practice scenarios, adapt content for varied audiences, and strengthen consistency. Validate all outputs with qualified reviewers, maintain traceability to source requirements, and ensure learning materials are accurate, engaging, accessible, and inspection ready and aligned with current procedures, policies, and regulatory expectations.

• Learning Delivery: Facilitate high-impact GxP training for employees and leaders, translating complex regulatory and procedural requirements into clear, practical expectations that support safe and consistent execution. Incorporate simulations, guided practice, knowledge checks, and coaching to build demonstrated competence, not attendance alone. Use AI-enabled learner insights to tailor reinforcement and improve pacing while preserving instructor judgment, psychological safety, and appropriate controls for regulated training decisions and clear accountability for required performance and follow-through.

• Onboarding Enablement: Lead the design and coordination of compliant onboarding and role-specific qualification experiences that shorten time to proficiency while protecting quality and patient safety. Align curricula, trainers, schedules, and evidence requirements across stakeholders, resolving execution risks before they affect readiness. Use AI-assisted workflow automation and personalization to scale communications, assignments, and reinforcement, while ensuring training completion, effectiveness, and qualification decisions remain accurate, documented, and appropriately approved throughout each employee learning journey.

Governance And Improvement

• System Governance: Administer and improve learning systems, curricula, assignments, training records, and documentation workflows with disciplined attention to accuracy, timeliness, access, and auditability. Maintain training matrices and completion evidence in accordance with procedures and data integrity expectations. Use AI-enabled monitoring to surface exceptions, overdue risk, and data anomalies faster, then investigate and resolve issues through controlled processes that strengthen compliance, visibility, and operational decision-making and reliable records for every assigned learning requirement.

• Effectiveness Measurement: Establish practical measures of training effectiveness using knowledge, behavior, quality, and operational indicators, moving beyond completion metrics to demonstrate business impact. Analyze learner performance, qualification outcomes, deviations, audit trends, and stakeholder feedback to identify improvement opportunities. Apply AI-supported pattern detection and summarization to accelerate insight generation, while validating conclusions and documenting decisions. Recommend actions that improve retention, execution quality, risk reduction, and return on learning investment across programs and populations.

• Trainer Capability: Build trainer and leader capability through train-the-trainer programs, facilitation standards, coaching, observation, and reusable instructional resources. Equip subject matter experts to deliver consistent, engaging, and compliant learning experiences across shifts and functions. Use AI tools to create practice cases, feedback prompts, and reinforcement assets at scale, while teaching responsible use, verification, and escalation. Foster accountability, learning agility, and continuous improvement within Empower’s regulated learning culture across teams, shifts, and sites.

KNOWLEDGE AND SKILLS

• Advanced knowledge of cGMP training, adult learning, instructional design, competency-based qualification, curriculum mapping, training matrices, and documentation controls in regulated operating environments.
• Proficiency with learning management systems, e-learning authoring platforms, Microsoft Office, data analysis, and approved AI tools used for content development, workflow automation, and insight generation.
• Strong facilitation, consulting, and cross-functional communication skills, with the judgment to translate complex requirements into practical learning solutions for employees, trainers, and leaders.
• Demonstrated capability in training effectiveness measurement, continuous improvement, audit readiness, data integrity, and risk-based prioritization across fast-changing, regulated, high-accountability operations.

KEY COMPETENCIES

• Customer Focus: Builds trust through customer-centric solutions.
• Strategic AI: Guides responsible AI adoption and adaptation.
• Optimizes Work Processes: Drives efficiency with continuous improvement.
• Collaborates: Partners effectively to achieve shared goals.
• Resourcefulness: Secures and deploys resources efficiently.
• Manages Complexity: Simplifies and solves complex challenges.
• Ensures Accountability: Delivers on commitments with integrity.
• Situational Adaptability: Adjusts approach to shifting conditions.
• Communicates Effectively: Tailors messages to diverse audiences.

EXPERIENCE AND QUALIFICATIONS

• Minimum of 3 years of experience in a training and instructional design role within a pharmaceutical, life sciences, healthcare, or other GxP-regulated environment.
• Requires a bachelor’s degree in education, life sciences, instructional design, or a related field; equivalent combination of education and experience may be considered.
• Strong facilitation, collaboration, and communication skills with the ability to tailor training for learners at all levels and cultivate a growth mindset organization wide.
• Proficiency in LMS, e-learning authoring tools, instructional design models, and Microsoft Office applications with a focus on documentation accuracy and training effectiveness in regulated environments.

SUPERVISORY RESPONSIBILITIES:

• This position does not have supervisory responsibilities.

CERTIFICATES, LICENSES, REGISTRATIONS: 

• Certification in instructional design, adult learning, or Learning and Development strongly preferred, including credentials such as Associate Professional in Talent Development (APTD), Certified Professional in Talent Development (CPTD), Training Within Industry (TWI), or a recognized Train-the-Trainer (TTT) program.