Global Head of cGMP Training

4w1 month ago

Sharp Services

Allentown, US · Full-time · $170,000 – $210,000

About this role

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 raises the quality, relevance, and consistency of training for GMP-impacting roles in manufacturing, packaging, labeling, laboratory, and warehousing.

Success comes from working with site Quality and Operations leaders to improve how training is designed, delivered, and sustained at the shop floor level. The role assesses the current state of GMP training using a risk-based lens and identifies high-impact gaps to reduce deviations, errors, rework, and inspection risk.

The role establishes a focused, phased improvement roadmap prioritizing critical GMP roles and high-risk processes. It leverages communities of practice to share practical learning across sites without unnecessary structure, and strengthens trainers as effective communicators of the 'why' behind cGMP requirements.

A critical focus is the practical deployment of Veeva Training 2.0 and expanding computer-based and blended learning for foundational concepts and refresher training. The goal is to mature training beyond task-based to smarter learning that improves performance, decision-making, and inspection readiness.

Requirements

Experience in cGMP training within pharmaceutical, biologics, or medical device manufacturing environments.
Deep knowledge of FDA, EU GMP, and global regulatory expectations for training and compliance.
Proven ability to lead global training improvement initiatives and influence cross-functional teams across multiple sites.
Experience with learning management systems (LMS) such as Veeva Training or similar platforms.
Strong understanding of shop floor operations, manufacturing processes, and quality systems in a regulated environment.
Demonstrated success in designing and implementing on-the-job training frameworks and trainer qualification programs.
Ability to assess training effectiveness and drive data-driven improvements to reduce deviations and inspection risks.

Responsibilities

Assess the current state of GMP training at Sharp with 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 critical GMP roles, high-risk processes, and sites with training opportunities.
Define which elements of key roles require structured, formalized on-the-job training, prioritizing those with direct impact on product quality, patient safety, and regulatory compliance.
Develop simple, consistent OJT frameworks that are clear and usable on the shop floor, focusing on both what to do and why it matters.
Lead the practical deployment and optimization of Veeva Training 2.0, Sharp’s global training administration and learning platform.
Expand the use of computer-based and blended learning for foundational cGMP concepts, refresher training, and common repeatable learning needs.
Strengthen the capability of trainers as communicators, not just task demonstrators, raising the overall quality of knowledge transfer and retention.