{"id":3050885,"url":"https://alion.io/job/icon-third-party-quality-lead","title":"Third Party Quality Lead","company":{"id":5677,"name":"ICON","domain":"iconplc.com","url":"https://alion.io/company/icon","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":49,"ghost_share":0,"stale_share":0.98,"repost_share":0,"time_to_fill_p50_days":12,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Sales","role_family":"Sales","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":["Blue Bell, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":71000,"max_usd":168000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1084},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-10-20T00:00:00Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-29T17:35:48Z","board_verified":true,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":10},"description":"Third Party Quality LeadAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.\nAs the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.\nAs a Third Party Quality Lead at ICON will play a key role in ensuring that contracted services and associated batch documentation meet applicable GMP, regulatory, client quality, and quality agreement requirements. This role also provides the opportunity to apply third-party quality management expertise in a cross-functional R&D\nResponsibilities include some of the following:\nAct as the primary day-to-day quality contact for assigned third parties and projects, working with internal stakeholders involved in activities contracted to those third parties.\nMonitor and support management of third-party quality performance and compliance with applicable GSK standards, quality requirements, current Good Manufacturing Practice (cGMP), regulatory requirements, and quality agreements.\nCoordinate and support quality governance meetings with assigned third parties, including preparation of quality performance information, documentation of actions, and follow-up to closure.\nDraft, coordinate, review, maintain, and support approval of quality agreements and related quality documentation, as applicable.\nReview and assess third-party quality management system records, including deviations, complaints, change controls, corrective and preventive actions (CAPAs), investigations, and validation-related documentation, and ensure timely follow-up in accordance with cGMP and quality agreements\nIdentify, assess, document, communicate, mitigate, and escalate quality issues and risks through the appropriate GSK quality governance pathways.\nReview and approve, or provide quality recommendations on, documentation required to support batch disposition/release activities within the scope of the engagement and applicable authorization.\nEnsure documentation associated with assigned third parties is appropriately reviewed, managed, retained, and archived in accordance with applicable requirements.\nSupport third-party selection, qualification, approval and maintenance of approval status, as appropriate to the assigned scope.\nParticipate in third-party audit planning, preparation , execution, response follow-up, and CAPA oversight, as applicable.\nProvide quality support for product or process transfers between GSK and third parties and for other assigned external manufacturing activities\nYour Profile:\nBachelor’s degree in pharmacy, Science, Engineering, or related discipline, or an equivalent level of knowledge, understanding, and hands-on GMP experience in the pharmaceutical environment.\nAt least 5 years of pharmaceutical manufacturing and or quality experience.\nPractical knowledge of cGMP principles and regulatory expectations applicable to pharmaceutical development and manufacturing.\nExperience reviewing or approving GMP manufacturing, laboratory, batch, validation, and/or quality system documentation.\nExperience supporting or leading quality system activities such as deviations, investigations, complaints, change controls, CAPAs, inspections, audits, and root-cause analysis.\nExperience working with external manufacturing organizations, suppliers, service providers, or other third parties.\nAbility to make sound risk- based quality decisions and escalate issues appropriately.\nProficient working knowledge of Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams.\nIf you have the following characteristics, it would be a plus:\nExperience providing quality oversight for contract manufacturing organizations supporting API, cell banking, drug substance, drug product, or investigational medicinal products.\nKnowledge of the pharmaceutical R&D lifecycle, including clinical development manufacturing and technology transfer.\nExperience with batch documentation review and disposition/release support.\nExperience with quality agreements, third-party quality governance, quality performance monitoring, and supplier qualification.\nAbility to work independently, manage competing priorities, and consistently deliver agreed outputs in a matrixed and deadline-driven environment.\nExcellent written and verbal communication skills, with the ability to build effective working relationships and influence internal and external stakeholders.\nStrong attention to detail, analytical thinking, problem identification, and problem -solving skills.\nEmployment with ICON is contingent upon having the legal right to work in the country where the role is based.\nRewards & Benefits\nICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.\nBenefits may include:\nCompetitive base salary and performance related incentives\nHealth and wellbeing programmes including medical, dental, and vision coverage where applicable\nRetirement and pension plans\nLife assurance and disability coverage\nEmployee assistance programmes and wellbeing resources\nLearning and development opportunities through structured training and career pathways\nBenefits may vary depending on role and location.\nVisit our careers site to read more about the benefits ICON offers.\nInclusion and Accessibility\nICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.\nIf you require reasonable accommodations during the recruitment process, please let us know or submit a request here.\nAre you a current ICON Employee? 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