{"id":726776,"url":"https://alion.io/job/seranbio-commercial-quality-control-manager","title":"Commercial Quality Control Manager","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":16,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":188,"computed_at":"2026-10-30T05:48:23Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","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":82000,"max_usd":154000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":6333},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"Chromatography","optional":false},{"name":"GMP","optional":false},{"name":"LIMS","optional":false}],"status":"live","first_seen_at":"2026-07-29T15:16:35Z","employer_posted_date":"2026-07-29","last_verified_at":"2026-10-30T18:18:34Z","board_verified":true,"closed_at":null,"days_open":93,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":91},"description":"Serán is expanding its Bend, Oregon campus with a new GMP manufacturing facility and is seeking an industry-experienced Commercial Quality Control Laboratory Manager to play a critical role in the facility start-up of the new QC laboratory including equipment and facility qualifications and FDA data integrity compliance. As a critical member of the Commercial Committee, the QC Commercial Laboratory Manager will be part of a cross-functional team who will plan and execute qualification projects, method transfers, validations, cleaning program, and computer system validations to support non-sterile pharmaceutical products.\nOnce the facility is underway, the Commercial Quality Control Manager will be responsible for leading the daily operations of the Commercial QC Laboratory in support of commercial manufacturing, raw material and product release, stability testing, and ongoing GMP compliance. This position ensures analytical testing is performed accurately, efficiently, and in compliance with current Good Manufacturing Practices (cGMP), ICH guidelines, FDA regulations, and company procedures.\nThe Commercial QC Laboratory Manager provides leadership to QC laboratory personnel, oversees laboratory scheduling and resource allocation, manages investigations, laboratory deviations, OOS/OOT events, change controls, and CAPAs, and partners closely with Manufacturing, Supply Chain, Analytical Development, and Quality Assurance to ensure timely release of commercial products.\nThis role is responsible for maintaining inspection readiness, driving operational excellence, developing laboratory personnel, and fostering a culture of quality, accountability, continuous improvement, and customer focus.\nSupervisor Responsibilities\nRecruit, interview, hire, onboard, train, and develop Quality Control laboratory personnel.\nProvide daily leadership, coaching, mentoring, and technical guidance to laboratory staff.\nEstablish performance expectations and conduct timely performance evaluations.\nAddress employee performance issues, and discipline, in accordance with company policies.\nPromote employee engagement, accountability, teamwork and continuous improvement.\nEnsure adequate staffing to support commercial manufacturing and laboratory operations.\nDuties/Responsibilities\nSupport qualification of new commercial lab including instrument and facility qualification.\nCollaborates with cross-functional teams to define equipment specifications, user requirements (URS), and establish project timelines and budgets.\nDevelops and executes protocols for equipment IQ/OQ/PQ in alignment with site validation master plans and project timelines.\nDrive readiness activities for commercial launch supporting method qualifications, validations, GMP documentation, and tech transfer from development to commercial.\nCollaborates with multidisciplinary teams to complete change controls, deviation investigations, and CAPA’s as required.\nCollaborate with the Facilities and Maintenance teams to establish preventative maintenance schedules.\nCollaborate with IT to complete computer system validations in alignment with 21 CFR Part 11 requirements.\nPartner with Validation, QA, and Manufacturing to ensure regulatory requirements.\nMaintain inspection readiness to support internal audits, client audits, and regulatory inspections, maintaining compliance with FDA, EMA, ICH, USP, EP, and other applicable regulatory requirements.\nLead laboratory investigations (OOS/OOT, deviations, atypical results) ensuring timely completions.\nManage daily operations of the Commercial Quality Control laboratory.\nSupport commercial batch release through timely execution of release, in-process, raw material, cleaning verification, stability testing, and documentation.\nCoordinate laboratory scheduling and prioritize testing activities to support manufacturing and customer commitments.\nMonitor laboratory workload, staffing, and turnaround times to ensure on-time product disposition.\nReview laboratory metrics and implement improvements to increase efficiency and effectiveness.\nEnsure laboratory documentation is accurate, complete, and compliant with ALCOA++ data integrity principles\nOversee stability program execution including protocol implementation, sample management, testing, and reporting.\nRequired Skills & Abilities\nStrong working knowledge of GMP, FDA, ICH, USP, and data integrity requirements.\nStrong understanding of commercial pharmaceutical manufacturing including lab development and method transfers.\nImplementing Leand and Six Sigma methodologies to reduce waste and improve process reliability.\nExperience managing analytical testing supporting commercial product release.\nExperience leading laboratory investigations including OOS, OOT, deviations, CAPAs, and change controls.\nStrong technical knowledge of instrument qualifications for chromatographic and analytical instrumentation.\nCoordinate with vendors and contractors to ensure timely and compliant start-up of laboratory systems.\nExperience with laboratory electronic systems including LIMS, Empower, NuGenesis, or equivalent.\nExcellent scientific writing and technical documentation skills.\nStrong organizational and project management abilities.\nCommunicates effectively and maintains productive relationships with coworkers, clients and other contacts outside of the company.\nStrong customer service and relationship management skills.\nAbility to manage multiple projects, create and work within internal timelines, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team.\nStrong analytical and critical thinking skills.\nExcellent leadership, coaching, and mentoring abilities.\nDemonstrated commitment to continuous improvement and operational excellence.\nPreference for those who possess knowledge of Global Regulatory requirements (FDA/MHRA/EMEA)\nEducation and Experience\nBachelor’s degreein chemistry, physics, engineering, or related scientific discipline\n\nPreference will be given to advanced degree holders or those with equivalent experience\n\n5-10 years of relevant experience in CDMOlaboratory\n\nRequires 5years of GMP experience\n\nPhysical Requirements\nProlonged periods of sitting at a desk and working on a computer.\n\nMust be able to lift up to 15 pounds at times.","description_format":"text","description_chars":6292,"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":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug 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