Manager, cGMP Training & Learning Programs

Serán BioScience • Bend, OR

5d • Onsite

About The Position

The cGMP Training Program Manager manages and continuously improves the organization’s GxP Training Program to ensure personnel are trained, qualified, and able to perform assigned responsibilities in compliance with applicable regulatory requirements and internal Quality Management System 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 establish sustainable training programs supporting clinical and commercial manufacturing operations. The position promotes quality, continuous learning, and regulatory compliance while ensuring training systems can scale with organizational growth.

The manager leads and develops the Training department, including setting goals, overseeing daily workflow, mentoring and evaluating staff, and fostering quality ownership and continuous improvement. The role owns the corporate GxP Training Program; maintains training policies and governance; administers LMS processes; develops role-based curricula and qualification programs; manages GMP onboarding; evaluates training effectiveness; and maintains training records in a state of inspection readiness. It also develops training metrics and reporting, partners with Quality Systems, and supports quality culture and workforce development initiatives.

The position requires consistent, predictable in-person attendance. The corporate headquarters are in Bend, Oregon. Applicants must be authorized to work in the United States; visa sponsorship is not available.

Requirements

• Bachelor’s degree in Life Sciences, Education, Organizational Development, Quality, Engineering, or a related discipline.
• 5–8 years of experience in pharmaceutical, biotechnology, medical device, or CDMO environments.
• At least 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 and influence personnel across organizational levels.
• Strong presentation and facilitation skills; excellent written and verbal communication skills.
• Exceptional organizational and project management skills, with strong analytical and problem-solving capabilities.
• Proficiency with LMS platforms, Microsoft Office, and electronic quality systems.
• Must be authorized to work for an employer in the United States; the employer cannot sponsor or take over sponsorship of an employment visa.
• Must maintain consistent and predictable in-person attendance.
• Must be able to lift up to 15 pounds.

Responsibilities

• Lead and develop a high-performing Training department; mentor, coach, develop, evaluate, and manage technical staff in accordance with company policy.
• Establish departmental goals and performance metrics aligned with organizational quality and operational objectives, oversee daily workflow, and ensure staff maintain appropriate training and GMP qualifications.
• Own and maintain the corporate GxP Training Program, including training policies, procedures, governance, and site-wide standards.
• Ensure training processes comply with applicable GxP regulations and industry requirements; monitor organizational training health and compliance.
• Manage training coordinators and administrators as applicable, and guide departmental trainers and subject matter experts, including supporting trainer and training-owner qualification.
• Maintain and optimize electronic LMS processes, assignments, user access, curricula, and workflows; partner with IT and system administrators on validation, upgrades, and enhancements.
• Ensure training records have appropriate data integrity and remain inspection-ready.
• Develop and maintain role-based curricula and learning paths; collaborate with department leaders to define competencies and qualification requirements and periodically assess training needs.
• Develop and maintain personnel qualification programs and standards for critical GMP activities; coordinate qualification and requalification and monitor ongoing competency requirements.
• Establish methods and tools to evaluate training effectiveness, comprehension, and competency; monitor human-error and training-related deviation trends and identify performance gaps and learning opportunities.
• Manage GMP onboarding, ensure required training is completed before independent work, coordinate cross-functional participation, and standardize processes across departments.
• Support client and internal audits and regulatory inspections; coordinate retrieval and presentation of training records and ensure training-related observations receive effective remediation.
• Partner with Quality Systems personnel to support the QMS and assess and implement training impacts when quality systems change.
• Develop training metrics and dashboards and provide routine reporting to leadership and Management Review.
• Lead continuous improvement in training, promote quality ownership and compliance, and develop educational programs that strengthen quality culture, learning effectiveness, and employee engagement.
• Support modern adult-learning principles and workforce development strategies.

Benefits

• More than four weeks of paid time off accrued annually.
• Employer retirement account contributions begin after 90 days and require no employee match or vesting period.
• Multiple health plan options with minimal employee contributions.
• Basic life insurance and long-term disability coverage, with options 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