SUMMARY:

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:

Near-Term Training Improvement Focus

• 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.

On-the-Job Training (OJT) & Trainer Capability

• Define which elements of key roles require structured, formalized OJT, prioritizing those with direct impact on:
  • Product quality
  • Patient safety
  • Regulatory compliance
• Develop simple, consistent OJT 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.

Use of Smart Digital & Computer-Based Training

• 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.

Training Effectiveness & Performance Impact

• 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.

Stakeholder Partnership & Governance

• Operate as a corporate enabler and coach, not a centralized owner of site training execution.
• Provide clear guidance and practical tools aligned with Global Quality Standards while respecting site accountability.
• Maintain awareness of evolving regulatory expectations for:
  • Qualified trainers
  • Training effectiveness
  • Workforce capability

while ensuring solutions remain operationally realistic and sustainable.

SUPERVISORY RESPONSIBILITIES:

None

EDUCATION AND EXPERIENCE:

• Bachelor's degree in Life Sciences, Engineering, Quality, or a related discipline, or equivalent combination of education and relevant cGMP experience.
• Minimum of 8-12 years of experience in pharmaceutical or regulated environments, with a strong foundation in cGMP operations and quality systems.
• Demonstrated experience in training, learning, or capability development, particularly within manufacturing, packaging, laboratory, or operational settings.
• Experience implementing or improving training effectiveness, including on-the-job training (OJT), trainer capability, and/or digital learning solutions preferred.
• Strong working knowledge of cGMP regulations, data integrity principles, and Pharmaceutical Quality Systems.
• Ability to translate regulatory requirements into practical, shop floor-ready training approaches.
• Proven ability to influence across sites and functions without direct authority.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.

Travel to customers on an as needed basis.

DISCLAIMER:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.