Manager, cGMP Training & Learning Programs

Serán BioScience • Bend, OR

4d • Onsite

About The Position

The cGMP Training Program Manager manages and continuously improves the organization’s GxP Training Program to ensure personnel are trained and qualified to perform their responsibilities in compliance with applicable regulatory requirements and internal Quality Management System (QMS) procedures. The role oversees training governance, curriculum development, learning management systems, training compliance, employee qualification programs, training effectiveness assessments, and inspection readiness related to personnel competency. It serves as the site subject matter expert for GxP training requirements and partners with functional departments to build sustainable programs supporting clinical and commercial manufacturing operations.

The manager leads and develops the Training department, sets goals aligned with quality and operational objectives, oversees daily workflow, and fosters quality ownership, compliance, and continuous improvement. The role owns the corporate GxP Training Program; maintains policies and procedures; administers LMS processes; develops role-based curricula and qualification programs; manages onboarding; evaluates training effectiveness; monitors metrics and compliance; and supports audits and regulatory inspections. It also partners with Quality Systems personnel to ensure training is appropriately supported and assessed when quality systems change.

The position requires a bachelor’s degree in a relevant discipline, at least 5–8 years of experience in pharmaceutical, biotechnology, medical device, or CDMO environments, and at least 3 years managing GxP training programs or quality systems. The role is based at Serán BioScience’s corporate headquarters in Bend, Oregon, and requires consistent, predictable in-person attendance. Applicants must be authorized to work in the U.S.; visa sponsorship is not available.

Requirements

• Bachelor’s degree in Life Sciences, Education, Organizational Development, Quality, Engineering, or a related discipline.
• A minimum of 5–8 years of experience in pharmaceutical, biotechnology, medical device, or CDMO environments.
• A minimum of 3 years managing GxP training programs or quality systems.
• Thorough understanding of FDA, EU, ICH, and cGMP training requirements.
• Strong knowledge of Quality Management Systems.
• Experience designing qualification and competency programs.
• Experience supporting client audits and regulatory inspections.
• Experience administering electronic learning management systems.
• Demonstrated understanding of cGMP regulations and personnel qualification requirements.
• Ability to collaborate and work in cross-functional teams.
• Strong presentation and facilitation skills.
• Strong organizational and project management skills.
• Ability to influence personnel across all organizational levels.
• Strong analytical and problem-solving capabilities.
• Excellent written and verbal communication skills.
• Proficiency with LMS platforms, Microsoft Office, and electronic quality systems.
• Must be able to lift up to 15 pounds at a time.
• Must maintain consistent and predictable in-person attendance.
• Must be authorized to work for an employer in the U.S.; the company is unable to sponsor or take over sponsorship of an employment visa.

Responsibilities

• Own and maintain the corporate GxP Training Program, including training policies, procedures, governance practices, and site-wide standards.
• Lead and develop the Training department, oversee its daily workflow, establish departmental goals and performance metrics, and provide staff mentoring, coaching, professional development, and performance evaluations.
• Ensure training processes comply with applicable GxP regulations, industry requirements, and internal QMS procedures.
• Manage training coordinators and administrators as applicable, and support departmental trainers, subject matter experts, training owners, and trainer qualification.
• Maintain and optimize electronic LMS processes, including user access, curricula, assignments, and workflows; partner with IT and system administrators on validation, upgrades, and enhancements.
• Ensure training records have data integrity and remain inspection-ready.
• Develop and maintain role-based curricula for cGMP functions and collaborate with department leaders to define competencies and qualification requirements.
• Develop and maintain personnel qualification programs, establish standards for critical GMP activities, coordinate qualification and requalification, and monitor ongoing competency requirements.
• Establish ways to evaluate training effectiveness, assess comprehension and competency, monitor human-error and training-related deviation trends, and drive improvements to training methods.
• Manage GMP onboarding, coordinate cross-functional participation, standardize onboarding across departments, and ensure required training is completed before employees work independently.
• Support client and internal audits and regulatory inspections, including retrieval and presentation of training records and remediation of training-related observations.
• Partner with Quality Systems personnel to provide training support for the QMS and assess and implement training impacts when quality systems change.
• Develop training performance metrics and dashboards and provide routine reporting to leadership and Management Review.
• Promote quality ownership, accountability, compliance, employee engagement, adult-learning principles, and workforce development.

Benefits

• Employees accrue over four weeks of paid time off annually.
• Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period.
• Various health plans are available with minimal employee contributions.
• Basic life and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program supporting employee wellbeing.
• Access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager