{"id":1293439,"url":"https://alion.io/job/advancell-us-site-quality-lead","title":"US Site Quality Lead","company":{"id":2044873,"name":"AdvanCell","domain":"advancell.com.au","url":"https://alion.io/company/advancell","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Andover, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":175000,"max":250000,"currency":"USD","period":"year","gross":null,"usd_annual":250000},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"LIMS","optional":true}],"status":"live","first_seen_at":"2026-09-16T16:46:02Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-10-27T07:45:04Z","board_verified":true,"closed_at":null,"days_open":40,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":40},"description":"The Director, Site Quality serves as the senior Quality leader for AdvanCell’s Andover manufacturing site and is responsible for the leadership, performance, and continuous improvement of all site Quality Assurance (QA) and Quality Control (QC) functions. Reporting to the VP, Global Head of Quality and serving as a member of the Site Leadership Team, the role provides strategic and operational leadership to ensure the effectiveness of the site Quality Management System (QMS) and compliance with applicable regulatory, GMP, radiation safety, and corporate quality requirements.\nThe Director, Site Quality is responsible for maintaining the independence, integrity, and effectiveness of the Quality organization while enabling the reliable manufacture, testing, release, and distribution of clinical and commercial radiopharmaceutical products. The role oversees Quality Systems, batch disposition and release, QC laboratory operations, validation and qualification oversight, supplier and external partner quality, inspection readiness, quality risk management, and continuous improvement.\nAs the Andover site progresses from construction and Phase 3 clinical manufacturing into commercial operations, this leader will establish and mature the site Quality organization, build a strong quality culture, and implement scalable systems and processes capable of supporting increasing manufacturing complexity, regulatory expectations, and business growth.\nThe Director, Site Quality will partner closely with Manufacturing, MSAT, Supply Chain, Regulatory Affairs, Clinical Operations, Engineering, EHS/Radiation Safety, Corporate Quality, and other functions, as well as external contract manufacturing organizations, testing laboratories, suppliers, and logistics providers.\nAs a member of the Site Leadership Team, the Director contributes to strategic planning, organizational development, risk management, and cross-functional decision-making. The role will provide independent Quality leadership while enabling the business to achieve its objectives and successfully transition the Andover site from startup through clinical manufacturing and into commercial GMP operations.\nKey Responsibilities and Duties\nQuality Leadership & Strategy\nServe as the senior Quality leader and member of the Site Leadership Team, contributing to site strategy, business planning, organizational development, and operational decision-making.\nEstablish and execute the site Quality strategy, objectives, priorities, and roadmap aligned with corporate quality and business goals.\nLead, develop, and mentor QA and QC teams, building a culture of quality, accountability, scientific rigor, continuous improvement, and employee engagement.\nMaintain the independence, authority, and integrity of the Quality organization in GMP decision-making.\nQuality Management System (QMS)\nEnsure the development, implementation, maintenance, and continuous improvement of an effective, risk-based QMS appropriate for a Phase 3 and commercial manufacturing environment.\nOversee core quality systems including deviations, CAPA, change control, investigations, complaints, risk management, supplier quality, document control, training, and management review.\nLead Quality Review Boards, Change Control Boards, CAPA governance, and Management Review processes.\nEstablish and monitor site quality metrics, quality plans, and performance indicators to identify trends, manage risk, and drive improvement.\nGMP Operations & Product Quality\nProvide independent Quality oversight of the manufacture, testing, release, storage, and distribution of radiopharmaceutical products.\nEnsure effective systems for raw material, component, intermediate, finished product, and batch record review and disposition.\nEstablish appropriate Quality oversight and release processes for clinical and commercial products.\nReview and approve GMP documentation, including procedures, specifications, investigations, change controls, validation protocols and reports, and quality agreements.\nEnsure product quality decisions are based on sound science, applicable regulations, approved procedures, and product specifications.\nQuality Control Oversight\nLead and oversee QC laboratory operations, including analytical testing, sampling, environmental monitoring, stability, and laboratory investigations.\nEnsure analytical methods, specifications, laboratory systems, equipment, and computerized systems are appropriately qualified, validated, and maintained.\nEnsure laboratory data integrity and timely, scientifically sound review and reporting of analytical results.\nPartner with MSAT, Manufacturing, and R&D to resolve analytical and product quality issues.\nValidation, Qualification & Technical Quality\nProvide Quality oversight of the qualification and validation of facilities, utilities, equipment, processes, analytical methods, and computerized systems.\nEnsure appropriate Quality involvement in commissioning, qualification, technology transfer, process validation, and process lifecycle management.\nSupport facility expansion, process scale-up, technology transfer, and commercialization readiness through risk-based Quality strategies.\nDrive quality improvement initiatives and implementation of risk-based approaches to quality management.\nSupplier & External Partner Quality\nEstablish and maintain appropriate Quality oversight of suppliers, contract manufacturers, testing laboratories, logistics providers, and other critical external partners.\nEnsure appropriate qualification, quality agreements, performance monitoring, audits, and risk management for critical suppliers and service providers.\nPartner with Supply Chain and Technical Operations to address supplier quality risks and ensure continuity of compliant supply.\nRegulatory Compliance & Inspection Readiness\nEnsure ongoing compliance with applicable cGMP, FDA, ICH, PIC/S, radiation safety, and other relevant regulatory requirements.\nEstablish and maintain continuous inspection readiness for FDA and other regulatory inspections, customer audits, and corporate quality audits.\nLead site Quality participation in regulatory inspections and ensure timely, effective responses to observations, commitments, and quality findings.\nServe as the site's senior Quality representative during regulatory interactions and inspections.\nQuality Culture, Safety & Compliance\nFoster a strong culture of quality, patient focus, safety, integrity, accountability, and continuous improvement across the site.\nEnsure Quality personnel maintain appropriate training, qualifications, and technical competencies.\nPartner with HSE/Radiation Safety to ensure appropriate Quality oversight of activities involving radioactive materials and applicable radiation safety, environmental, and transport requirements.\nPromote proactive identification and escalation of quality and compliance risks.\nResource & Financial Management\nDevelop and manage Quality staffing plans, budgets, external resources, and organizational capabilities to support Phase 3 and future commercial operations.\nRecruit, develop, and retain high-performing Quality professionals and establish effective succession planning.\nScale the Quality organization, systems, and capabilities in line with the evolving needs of the Andover site and broader AdvanCell network.\nEssential Skills, Responsibilities, Industry and Educational Requirements\nBachelor's degree in Pharmacy, Chemistry, Biochemistry, Microbiology, Engineering, Life Sciences, or a related scientific discipline.\n12+ years of progressive experience in pharmaceutical, biotechnology, radiopharmaceutical, biologics, sterile manufacturing, or related regulated industries.\n7+ years of leadership experience managing Quality Assurance, Quality Control, or site quality organizations.\nDemonstrated experience leading and maintaining GMP Quality Management Systems within regulated manufacturing environments.\nStrong knowledge of global GMP regulations and quality standards, including TGA, FDA, EMA, PIC/S, ICH, and applicable quality system requirements.\nExperience leading regulatory inspections, including preparation, hosting, response management, and closure of observations.\nProven experience managing deviations, CAPAs, change controls, validation programs, investigations, and batch disposition activities.\nStrong leadership, communication, stakeholder management, and decision-making skills.\nAbility to influence across functions and levels of the organization while maintaining quality independence.\nDemonstrated ability to build high-performing teams and develop technical and leadership capability.\nStrong analytical, problem-solving, and risk management skills. \nDesired Skills, Responsibilities, Industry and Educational Requirements\nAdvanced degree (MSc, PhD, PharmD, or equivalent) in a scientific, engineering, or related discipline.\nExperience in just-in-time radiopharmaceutical manufacturing, nuclear medicine, radiochemistry, or radioactive materials management.\nExperience supporting clinical-stage products through commercialization and regulatory approval.\nKnowledge of radiation safety requirements and regulations applicable to radiopharmaceutical manufacturing and distribution.\nExperience with aseptic processing, sterile manufacturing, and/or highly potent compounds.\nExperience supporting technology transfers, facility start-up, commissioning, qualification, and validation activities.\nFamiliarity with computerized quality systems, electronic batch records, LIMS, ERP, and data integrity requirements.\nCertification in Quality Management, Lean Six Sigma, Operational Excellence, or related disciplines.\nExperience establishing and scaling quality organizations within rapidly growing or emerging biotechnology 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