{"id":3126613,"url":"https://alion.io/job/seran-bioscience-manager-cgmp-training-learning-programs","title":"Manager, cGMP Training & Learning Programs","company":{"id":686143,"name":"Serán Bioscience","domain":"seranbio.com","url":"https://alion.io/company/seranbio","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"A","score":95,"open_postings":17,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":188,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bend, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":77000,"max_usd":144000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4487},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-22T23:42:04Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-25T11:59:42Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"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.\nLeader Responsibilities\nLeads and develops a high-performing Training department\nProvides mentoring, coaching, and professional development for technical staff; provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy\nEstablish clear departmental goals aligned with organizational quality and operational objectives\nConducts performance reviews and ensure staff maintain appropriate training and GMP qualifications\nFosters a culture of quality ownership, compliance, and continuous improvement\nOversees daily workflow of the department\nDuties & Responsibilities\nOwn and maintain the corporate GxP Training Program.\nDevelop and maintain training policies, procedures, and governance practices.\nEnsure training processes comply with applicable GxP regulations and industry requirements.\nEstablish systems supporting employee onboarding, qualification, retraining, and continuing education.\nMonitor organizational training health and compliance.\nManage training coordinators and training administrators as applicable.\nProvide guidance and support to departmental trainers and subject matter experts.\nDevelop training governance and site-wide training standards.\nSupport qualification of trainers and training owners.\nEstablish departmental objectives and performance metrics.\nLead continuous improvement initiatives within the training function.\nLearning Management System Administration\nMaintain and optimize electronic Learning Management System (LMS) processes.\nEnsure training assignments are current, accurate, and aligned to job responsibilities.\nOversee user access, curricula management, and training workflows.\nPartner with Information Technology and system administrators on validation, upgrades, and enhancements.\nEnsure data integrity and inspection readiness of training records.\nRole-Based Curriculum Development\nDevelop and maintain role-based training curricula for all cGMP functions.\nEnsure curricula accurately reflect required competencies and job functions.\nCollaborate with department leaders to define qualification requirements.\nPeriodically assess training requirements to ensure continued effectiveness and compliance.\nSupport creation of learning paths for new and existing employees.\nEmployee Qualification Program\nDevelop and maintain personnel qualification programs.\nEnsure qualification requirements are documented and consistently applied.\nEstablish qualification standards for critical GMP activities.\nCoordinate qualification and requalification activities.\nMonitor ongoing competency requirements.\nTraining Effectiveness Program\nEstablish mechanisms to evaluate training effectiveness.\nDevelop tools to assess employee comprehension and competency.\nMonitor trends related to human error and training-related deviations.\nCollaborate with management to identify performance gaps and targeted learning opportunities.\nDrive continual improvements to training methodologies.\nNew Employee Onboarding\nManage GMP onboarding programs for new employees.\nEnsure timely completion of required training prior to independent work.\nCoordinate cross-functional participation in onboarding activities.\nStandardize onboarding processes across departments.\nInspection Readiness Support\nMaintain training records in a state of continuous inspection readiness.\nSupport client audits, internal audits, and regulatory inspections.\nCoordinate retrieval and presentation of training records during inspections.\nEnsure training-related observations are addressed through effective remediation plans.\nMetrics and Compliance Monitoring\nPartner 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.\nDevelop and maintain training performance metrics and dashboards.\nProvide routine reporting to leadership and Management Review.\nQuality Culture & Continuous Improvement\nPromote a culture of ownership, accountability, and compliance.\nDevelop educational programs that strengthen quality culture across the organization.\nIdentify opportunities to improve learning effectiveness and employee engagement.\nSupport implementation of modern adult-learning principles and workforce development strategies.\nRequired Skills & Abilities\nThorough understanding of FDA, EU, ICH, and cGMP training requirements.\nStrong knowledge of Quality Management Systems.\nExperience designing qualification and competency programs.\nDemonstrated ability to collaborate and work in cross-functional teams.\nStrong presentation and facilitation skills.\nExceptional organizational and project management skills.\nAbility to influence personnel across all organizational levels.\nStrong analytical and problem-solving capabilities.\nExcellent written and verbal communication skills.\nProficiency with LMS platforms, Microsoft Office, and electronic quality systems.\nEducation & Experience\nBachelor's degree in Life Sciences, Education, Organizational Development, Quality, Engineering, or related discipline required.\nMinimum of 5-8 years of experience in pharmaceutical, biotechnology, medical device, or CDMO environments.\nMinimum of 3 years managing GxP training programs or quality systems.\nExperience supporting client audits and regulatory inspections.\nExperience administering electronic learning management systems.\nDemonstrated understanding of cGMP regulations and personnel qualification requirements.\nPhysical Requirements\nProlonged periods of sitting or standing at a desk and working on a computer.\nMust be able to lift up to 15 pounds at a time\nAdheres to consistent and predictable in-person attendance","description_format":"text","description_chars":6700,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-23T02:14:14Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":188,"reasons":["conf:1","win:early"],"computed_at":"2026-10-25T05:49:26Z"},"pay":null,"html_url":"https://alion.io/job/seran-bioscience-manager-cgmp-training-learning-programs","json_url":"https://alion.io/job/seran-bioscience-manager-cgmp-training-learning-programs.json","meta":{"generated_at":"2026-10-25T14:52:51Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":21443,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":686143},"rest":"https://alion.io/mcp/rest/get_company?id=686143"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fseran-bioscience-manager-cgmp-training-learning-programs"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fseran-bioscience-manager-cgmp-training-learning-programs"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fseran-bioscience-manager-cgmp-training-learning-programs"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/seran-bioscience-manager-cgmp-training-learning-programs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fseran-bioscience-manager-cgmp-training-learning-programs"}]}