Global Head of cGMP Training

Global Head Of Cgmp Training

The Global Head of cGMP Training is a corporate quality position responsible for strengthening the effectiveness of cGMP training across Sharp's global network, with an immediate focus on improving shop floor and operational training.

This role is accountable for raising the quality, relevance, and consistency of training for GMP-impacting roles, particularly within manufacturing, packaging, labeling, laboratory, and warehousing operations. The emphasis of the role is to mature training beyond foundational and task-based to smarter and more effective learning that improves performance, decision-making, and inspection readiness.

Success in this role will come from working with site Quality and Operations leaders to improve how training is designed, delivered, and sustained especially at the shop floor level, while ensuring solutions remain fit-for-purpose, scalable, and sustainable.

A critical focus of the role is strengthening trainers and on-the-job training, ensuring that those delivering training are not only technically competent, but are also effective communicators of the "why" behind cGMP requirements, process controls, and data integrity expectations.

Essential Duties & Responsibilities:

• Assess the current state of GMP training at Sharp, with specific emphasis on shop floor, operational, and laboratory roles, using a risk-based and pragmatic lens.
• Identify specific, high-impact gaps where improved training will meaningfully reduce deviations, right-first-time errors, rework, and inspection risk.
• Establish a focused, phased improvement roadmap that prioritizes:
  • GMP activities related to critical GMP roles
  • GMP activities and processes that are high-risk.
  • Sites or functions with opportunities in training and learning
  • Using communities of practice to share practical learning and best practices across sites, without creating unnecessary structure or overhead.
• Avoid over-engineering or large-scale redesigns in the near term; prioritize incremental, practical improvement that can be implemented and sustained.

• Define which elements of key roles require structured, formalized on-the-job training, prioritizing those with direct impact on:
  • Product quality
  • Patient safety
  • Regulatory compliance
• Develop simple, consistent on-the-job training frameworks that:
  • Are clear and usable on the shop floor.
  • Focus on both what to do and why it matters.
  • Can be adapted locally based on process complexity and risk.
• Establish clear and realistic expectations for trainer qualification, including:
  • Technical competence in the process
  • Ability to explain underlying cGMP principles.
  • Understanding of data integrity and regulatory expectations
• Strengthen the capability of trainers as communicators, not just task demonstrators, raising the overall quality of knowledge transfer and retention.

• Lead the practical deployment and optimization of Veeva's Training 2.0 - Sharp's global training administration and learning platform.
• Expand the use of computer-based and blended learning (combining classroom instruction with online/asynchronous digital learning), particularly for:
  • Foundational cGMP concepts
  • Refresher training
  • Common, repeatable learning needs
• Drive digital learning to be:
  • Clear, concise, and relevant
  • Designed for the realities of the shop floor environment.
  • Used to support hands-on training.
• Explore targeted, low-complexity uses of emerging technology (including AI) only where it clearly improves efficiency or effectiveness, avoiding experimental or administrative burden.

• Move training evaluation beyond completion metrics to simple, meaningful indicators, such as:
  • Trends in deviations and repeat errors
  • Quality events linked to training gaps
  • Right-first-time and execution errors
• Work with sites to diagnose where training quality, not just adherence, is contributing to performance issues and implement focused, practical improvements.
• Ensure training improvements are deliberately linked to PQS maturity, process robustness, and inspection readiness, consistent with Sharp's quality priorities.

• Operate as a corporate enabler and coach, not a centralized owner of site training execution.
• Provide clear guidance and practical tools…