{"schemaVersion":"jobsearcher.job.v1","id":"13d98f82ae76fedc01405f3b","url":"https://jobsearcher.com/jobs/13d98f82ae76fedc01405f3b","canonicalUrl":"https://jobsearcher.com/jobs/13d98f82ae76fedc01405f3b","title":"Manager, cGMP Training & Learning Programs","description":"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 ResponsibilitiesThis position requires experience working in a GMP facility.Leads and develops a high-performing Training departmentProvides mentoring, coaching, and professional development for technical staff; provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policyEstablish clear departmental goals aligned with organizational quality and operational objectivesConducts performance reviews and ensure staff maintain appropriate training and GMP qualificationsFosters a culture of quality ownership, compliance, and continuous improvementOversees daily workflow of the departmentDuties & ResponsibilitiesOwn and maintain the corporate GxP Training ProgramDevelop and maintain training policies, procedures, and governance practicesEnsure training processes comply with applicable GxP regulations and industry requirementsEstablish systems supporting employee onboarding, qualification, retraining, and continuing educationMonitor organizational training health and complianceManage training coordinators and training administrators as applicableProvide guidance and support to departmental trainers and subject matter expertsDevelop training governance and site-wide training standardsSupport qualification of trainers and training ownersEstablish departmental objectives and performance metricsLead continuous improvement initiatives within the training functionLearning Management System AdministrationMaintain and optimize electronic Learning Management System (LMS) processesEnsure training assignments are current, accurate, and aligned to job responsibilitiesOversee user access, curricula management, and training workflowsPartner with Information Technology and system administrators on validation, upgrades, and enhancementsEnsure data integrity and inspection readiness of training recordsRole-Based Curriculum DevelopmentDevelop and maintain role-based training curricula for all cGMP functionsEnsure curricula accurately reflect required competencies and job functionsCollaborate with department leaders to define qualification requirementsPeriodically assess training requirements to ensure continued effectiveness and complianceSupport creation of learning paths for new and existing employeesEmployee Qualification ProgramDevelop and maintain personnel qualification programsEnsure qualification requirements are documented and consistently appliedEstablish qualification standards for critical GMP activitiesCoordinate qualification and requalification activitiesMonitor ongoing competency requirementsTraining Effectiveness ProgramEstablish mechanisms to evaluate training effectivenessDevelop tools to assess employee comprehension and competencyMonitor trends related to human error and training-related deviationsCollaborate with management to identify performance gaps and targeted learning opportunitiesDrive continual improvements to training methodologiesNew Employee OnboardingManage GMP onboarding programs for new employeesEnsure timely completion of required training prior to independent workCoordinate cross-functional participation in onboarding activitiesStandardize onboarding processes across departmentsInspection Readiness SupportMaintain training records in a state of continuous inspection readinessSupport client audits, internal audits, and regulatory inspectionsCoordinate retrieval and presentation of training records during inspectionsEnsure training-related observations are addressed through effective remediation plansMetrics and Compliance MonitoringPartner 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 changeDevelop and maintain training performance metrics and dashboardsProvide routine reporting to leadership and Management ReviewQuality Culture & Continuous ImprovementPromote a culture of ownership, accountability, and complianceDevelop educational programs that strengthen quality culture across the organizationIdentify opportunities to improve learning effectiveness and employee engagementSupport implementation of modern adult-learning principles and workforce development strategiesRequired Skills & AbilitiesThorough understanding of FDA, EU, ICH, and cGMP training requirementsStrong knowledge of Quality Management SystemsExperience designing qualification and competency programsDemonstrated ability to collaborate and work in cross-functional teamsStrong presentation and facilitation skillsExceptional organizational and project management skillsAbility to influence personnel across all organizational levelsStrong analytical and problem-solving capabilitiesExcellent written and verbal communication skillsProficiency with LMS platforms, Microsoft Office, and electronic quality systemsEducation & ExperienceBachelor's degree in Life Sciences, Education, Organizational Development, Quality, Engineering, or related discipline requiredMinimum of 5-8 years of experience in pharmaceutical, biotechnology, medical device, or CDMO environmentsMinimum of 3 years managing GxP training programs or quality systemsExperience supporting client audits and regulatory inspectionsExperience administering electronic learning management systemsDemonstrated understanding of cGMP regulations and personnel qualification requirementsPhysical RequirementsProlonged periods of sitting or standing at a desk and working on a computerMust be able to lift up to 15 pounds at a timeAdheres to consistent and predictable in-person attendanceVisit 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 97701We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.","company":"Seran Bioscience","rawCompany":"seran bioscience","city":"Big Bend","state":"WI","isRemote":false,"isActive":false,"createdAt":"2026-11-02T07:06:08.656Z","occupations":[{"code":"11-3131.00","title":"Training and Development Managers","slug":"training-and-development-managers"},{"code":"13-1151.00","title":"Training and Development Specialists","slug":"training-and-development-specialists"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"611430","title":"Professional and Management Development Training","slug":"professional-and-management-development-training"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"611420","title":"Computer Training","slug":"computer-training"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Manager, cGMP Training & Learning Programs","description":"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 ResponsibilitiesThis position requires experience working in a GMP facility.Leads and develops a high-performing Training departmentProvides mentoring, coaching, and professional development for technical staff; provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policyEstablish clear departmental goals aligned with organizational quality and operational objectivesConducts performance reviews and ensure staff maintain appropriate training and GMP qualificationsFosters a culture of quality ownership, compliance, and continuous improvementOversees daily workflow of the departmentDuties & ResponsibilitiesOwn and maintain the corporate GxP Training ProgramDevelop and maintain training policies, procedures, and governance practicesEnsure training processes comply with applicable GxP regulations and industry requirementsEstablish systems supporting employee onboarding, qualification, retraining, and continuing educationMonitor organizational training health and complianceManage training coordinators and training administrators as applicableProvide guidance and support to departmental trainers and subject matter expertsDevelop training governance and site-wide training standardsSupport qualification of trainers and training ownersEstablish departmental objectives and performance metricsLead continuous improvement initiatives within the training functionLearning Management System AdministrationMaintain and optimize electronic Learning Management System (LMS) processesEnsure training assignments are current, accurate, and aligned to job responsibilitiesOversee user access, curricula management, and training workflowsPartner with Information Technology and system administrators on validation, upgrades, and enhancementsEnsure data integrity and inspection readiness of training recordsRole-Based Curriculum DevelopmentDevelop and maintain role-based training curricula for all cGMP functionsEnsure curricula accurately reflect required competencies and job functionsCollaborate with department leaders to define qualification requirementsPeriodically assess training requirements to ensure continued effectiveness and complianceSupport creation of learning paths for new and existing employeesEmployee Qualification ProgramDevelop and maintain personnel qualification programsEnsure qualification requirements are documented and consistently appliedEstablish qualification standards for critical GMP activitiesCoordinate qualification and requalification activitiesMonitor ongoing competency requirementsTraining Effectiveness ProgramEstablish mechanisms to evaluate training effectivenessDevelop tools to assess employee comprehension and competencyMonitor trends related to human error and training-related deviationsCollaborate with management to identify performance gaps and targeted learning opportunitiesDrive continual improvements to training methodologiesNew Employee OnboardingManage GMP onboarding programs for new employeesEnsure timely completion of required training prior to independent workCoordinate cross-functional participation in onboarding activitiesStandardize onboarding processes across departmentsInspection Readiness SupportMaintain training records in a state of continuous inspection readinessSupport client audits, internal audits, and regulatory inspectionsCoordinate retrieval and presentation of training records during inspectionsEnsure training-related observations are addressed through effective remediation plansMetrics and Compliance MonitoringPartner 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 changeDevelop and maintain training performance metrics and dashboardsProvide routine reporting to leadership and Management ReviewQuality Culture & Continuous ImprovementPromote a culture of ownership, accountability, and complianceDevelop educational programs that strengthen quality culture across the organizationIdentify opportunities to improve learning effectiveness and employee engagementSupport implementation of modern adult-learning principles and workforce development strategiesRequired Skills & AbilitiesThorough understanding of FDA, EU, ICH, and cGMP training requirementsStrong knowledge of Quality Management SystemsExperience designing qualification and competency programsDemonstrated ability to collaborate and work in cross-functional teamsStrong presentation and facilitation skillsExceptional organizational and project management skillsAbility to influence personnel across all organizational levelsStrong analytical and problem-solving capabilitiesExcellent written and verbal communication skillsProficiency with LMS platforms, Microsoft Office, and electronic quality systemsEducation & ExperienceBachelor's degree in Life Sciences, Education, Organizational Development, Quality, Engineering, or related discipline requiredMinimum of 5-8 years of experience in pharmaceutical, biotechnology, medical device, or CDMO environmentsMinimum of 3 years managing GxP training programs or quality systemsExperience supporting client audits and regulatory inspectionsExperience administering electronic learning management systemsDemonstrated understanding of cGMP regulations and personnel qualification requirementsPhysical RequirementsProlonged periods of sitting or standing at a desk and working on a computerMust be able to lift up to 15 pounds at a timeAdheres to consistent and predictable in-person attendanceVisit 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 97701We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.","datePosted":"2026-11-02T07:06:08.656Z","dateModified":"2026-11-02T07:06:08.656Z","hiringOrganization":{"@type":"Organization","name":"Seran Bioscience","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Big Bend","addressRegion":"WI","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"13d98f82ae76fedc01405f3b"},"url":"https://jobsearcher.com/jobs/13d98f82ae76fedc01405f3b"}}