Über diese Manager, cGMP Training & Learning Programs Stelle bei Seranbio
Seranbio · Vor Ort · Bend, Oregon
The cGMP Training Program Manager is responsible for managing and continuously improving the organization's GxP Training Program to ensure personnel are trained, qualified, and capable of performing assigned responsibilities in compliance with applicable regulatory requirements and internal Quality Management System (QMS) procedures. This role oversees training governance, curriculum development, learning management systems, training compliance, employee qualification programs, training effectiveness assessments, and inspection readiness related to personnel competency. The position serves as the site Subject Matter Expert for GxP training requirements and partners with all functional departments to establish sustainable training programs that support clinical and commercial manufacturing operations. The cGMP Training Program Manager promotes a culture of quality, continuous learning, and regulatory compliance while ensuring training systems remain scalable to support organizational growth.
Leader Responsibilities
- Leads and develops a high-performing Training department
- Provides mentoring, coaching, and professional development for technical staff; provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy
- Establish clear departmental goals aligned with organizational quality and operational objectives
- Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications
- Fosters a culture of quality ownership, compliance, and continuous improvement
- Oversees daily workflow of the department
Duties & Responsibilities
Learning Management System Administration
- Maintain and optimize electronic Learning Management System (LMS) processes.
- Ensure training assignments are current, accurate, and aligned to job responsibilities.
- Oversee user access, curricula management, and training workflows.
- Partner with Information Technology and system administrators on validation, upgrades, and enhancements.
- Ensure data integrity and inspection readiness of training records.
- Develop and maintain role-based training curricula for all cGMP functions.
- Ensure curricula accurately reflect required competencies and job functions.
- Collaborate with department leaders to define qualification requirements.
- Periodically assess training requirements to ensure continued effectiveness and compliance.
- Support creation of learning paths for new and existing employees.
- Develop and maintain personnel qualification programs.
- Ensure qualification requirements are documented and consistently applied.
- Establish qualification standards for critical GMP activities.
- Coordinate qualification and requalification activities.
- Monitor ongoing competency requirements.
- Establish mechanisms to evaluate training effectiveness.
- Develop tools to assess employee comprehension and competency.
- Monitor trends related to human error and training-related deviations.
- Collaborate with management to identify performance gaps and targeted learning opportunities.
- Drive continual improvements to training methodologies.
- Manage GMP onboarding programs for new employees.
- Ensure timely completion of required training prior to independent work.
- Coordinate cross-functional participation in onboarding activities.
- Standardize onboarding processes across departments.
- Maintain training records in a state of continuous inspection readiness.
- Support client audits, internal audits, and regulatory inspections.
- Coordinate retrieval and presentation of training records during inspections.
- Ensure training-related observations are addressed through effective remediation plans.
- Partner closely with Quality Systems personnel to ensure appropriate training support for the QMS and ensure training impacts are appropriately assessed and implemented when quality systems change.
- Develop and maintain training performance metrics and dashboards.
- Provide routine reporting to leadership and Management Review.
- Promote a culture of ownership, accountability, and compliance.
- Develop educational programs that strengthen quality culture across the organization.
- Identify opportunities to improve learning effectiveness and employee engagement.
- Support implementation of modern adult-learning principles and workforce development strategies.
Role-Based Curriculum Development
Employee Qualification Program
Training Effectiveness Program
New Employee Onboarding
Inspection Readiness Support
Metrics and Compliance Monitoring
Quality Culture & Continuous Improvement
Required Skills & Abilities
Education & Experience
Physical Requirements
Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán 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 allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701
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