{"id":1131339,"url":"https://alion.io/job/zentiva-external-quality-management-supplier-compliance-manager","title":"External Quality Management & Supplier Compliance Manager","company":{"id":203016,"name":"Zentiva","domain":"zentiva.lv","url":"https://alion.io/company/zentiva","size_band":"501-1000","is_staffing_agency":false,"is_intermediary":false,"ats_vendor":"Workday","truth_index":{"grade":"A","score":92,"open_postings":3,"ghost_share":0,"stale_share":0.333,"repost_share":0,"time_to_fill_p50_days":50,"computed_at":"2026-09-23T05:45:00Z"}},"role":"Management","role_family":"Management","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"hiring_geo_confidence":"structured","locations":["Ankleshwar, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":42000,"max_usd":98000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":464},"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-23T03:36:38Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-09-23T10:09:20Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Position title: External Quality Management & Supplier Compliance- Manager\nREQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS\nTechnical University Degree (health, pharma, technical, chemical areas are advantage)\n12+ years industry experience specifically in GxP with a strong understanding of international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable.\nExperience in supplier qualification, outsourced activity management, Quality Agreements and supplier auditing is highly desirable.\nStrong experience in area of GxP related to change control, deviation, quality processes and document management.\nOrganizational and analytical skills associated with proficiency in quality management and continuous improvement.\nCritical thinking ability and risk management and risk- based knowledge and approach.\nAbility in partnering with a proactive and solution- oriented approach.\nStrong skills to facilitate/optimize contribution of team members as individuals and members of a quality function\nAbility to work effectively in a matrix cross-functional environment.\nStrong capacity for working independently with minimal supervision.\nAbility to make & communicate difficult decisions, associated with strong written and verbal communication skills. (English language in writing and speaking)\nSelf-awareness, willingness to further develop own strengths and explore opportunities for improvement.\nJob Purpose: The Manager, External Quality Management & Supplier Compliance is responsible for leading the centralized Third Party Quality Management function within the Quality Shared Services Centre (QSSC). The role combines people leadership with operational ownership of supplier qualification, Third Party lifecycle management, audit coordination, Quality Agreement management, supplier risk assessment, CAPA oversight and Quality Forward administration.\nResponsible for final review and approval of Third Party qualification packages, Supplier Risk Ranking Tools (RRTs), Quality Technical Agreements (QTAs), and associated Quality Forward records within delegated authority.\nMAIN ACCOUNTABILITIES AND DUTIES\nPeople LeadershipManage, coach and develop External Quality Management Specialists and Experts.\nBuild and maintain team capability in supplier qualification, auditing, Quality Agreements, supplier risk assessment, CAPA management and Quality Forward administration.\nDefine training plans, competency frameworks, succession planning and knowledge sharing within the function.\nMonitor resource allocation, workload distribution and service delivery performance.\nFoster a culture of quality, accountability, inspection readiness and continuous improvement.\n\nExternal Quality Governance & Workstream LeadershipLead the External Quality Management workstream within QSSC.\nEstablish and maintain standardized processes, templates, trackers, and governance mechanisms.\nEnsure compliance with corporate supplier quality requirements, GMP expectations, Quality Agreements and outsourced activity requirements.\nDrive harmonization across affiliates and sites for TP management activities\n\nThird Party Lifecycle ManagementOversee creation and maintenance of Third Party records in Quality Forward.\nEnsure execution of TP onboarding, qualification, update, suspension, and discontinuation activities.\nGovern TP lifecycle change controls and associated documentation.\nMonitor status and completeness of supplier records and qualification packages.\nDrive timely completion of qualification activities and escalations.\n\nAudit Management & OversightLead audit planning and audit request management.\nOversee paper assessments, desktop audits and contracted audit administration.\nMonitor audit schedules and supplier audit compliance.\nSupport inspection readiness associated with outsourced partners and suppliers.\n\n Quality Agreement ManagementOversee preparation, review, revision and maintenance of Quality Technical Agreements (QTAs).\nEnsure QTA responsibilities are clearly defined and regularly reviewed.\nSupport affiliates and sites with standardized agreement templates.\nMonitor execution status and renewal requirements.\n\n Supplier Risk Management & QualificationEnsure execution of Supplier Risk Ranking Tools (RRTs).\nMonitor supplier risk profiles and audit frequency requirements.\nReview supplier risk trends and recommend mitigation actions.\nEnsure risk assessments are appropriately documented and maintained in QF.\nSupport risk-based supplier qualification decisions.\n\nContinuous Improvement & DigitalizationDrive simplification and standardization of supplier quality processes.\nPromote effective use of Quality Forward, digital workflows, dashboards and metrics.\nIdentify opportunities to reduce manual activities and improve process efficiency.\nLead lessons learned and process improvement initiatives arising from audits, supplier issues and inspection findings.\nEstablish and monitor KPIs related to supplier qualification cycle time, audit execution, QTA completion, CAPA closure, overdue actions, supplier risk levels and compliance performance.\n\nStakeholder Management & Inspection ReadinessAct as primary QSSC contact for supplier quality activities.\nPartner with Procurement, Supply Chain, Manufacturing, Regulatory Affairs, Quality Systems and Site Quality.\nSupport health authority inspections and internal audits involving outsourced activities.\nEnsure supplier qualification and audit documentation is inspection ready at all times.\n\n Technical Approval & Quality OversightAct as designated QSSC quality approver for Third Party qualification records, Quality Agreements, Risk Ranking Tools and associated supplier quality documentation within delegated authority\nPerform final review of Supplier Risk Ranking Tool (RRT) assessments and challenge risk classification, audit frequency and proposed mitigation actions where required\nPerform final review and approval of Quality Technical Agreements (QTAs) prior to routing to relevant site, affiliate or supplier stakeholders.\nReview and approve creation, update, qualification, suspension, or discontinuation activities associated with Third Party records in Quality Forward in accordance with approved procedures.\nReview and approve Quality Forward records related to supplier lifecycle activities, ensuring completeness, accuracy and compliance of supporting documentation\nReview audit outcomes, paper assessments, supplier qualification documentation and CAPA proposals before escalation to responsible Quality functions\nEnsure supplier qualification decisions, audit recommendations and risk assessments are appropriately documented, justified and inspection ready.\n\nCAPA Management & Supplier Effectiveness MonitoringReview and approve CAPA plans resulting from supplier audits, paper assessments, Quality Agreements reviews, supplier quality events and risk evaluations.\nEnsure CAPAs are assigned, tracked and escalated through to closure within agreed timelines\nReview objective evidence supporting CAPA completion and effectiveness verification.\nMonitor recurring audit findings, repeat deficiencies and supplier performance trends and recommend additional mitigation activities when required.\nMaintain oversight of supplier quality performance metrics and CAPA effectiveness indicators.\nReview supplier quality performance trends including audit findings, complaints, delivery performance, recurring CAPAs and regulatory observations to identify suppliers requiring enhanced oversight.\n\nOTHER RESPONSIBILITIES\nQUALITY\nAdheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.\nHSE\nAdheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.\nPHARMACOVIGILANCE\nAll employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations.\nCOMPLIANCE*\n*) country specific\nThe employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents.\nSUSTAINABILITY\nAdheres to the principles of ESG detailed in the Sustainability Strategy and its 3 pillars People, Partners and the Planet\nMANAGERIAL POSITIONS REQUIRE:\nGood communication and adaptability to different portfolio projects and acquisitions, leadership of transversal teams in quality, participation in transversal project/acquisition teams, good planning, quick learning, broad quality knowledge, systematic tracking.\nCOMMUNICATIONS & WORKING RELATIONSHIPS\nInternal\nCommunicate with all relevant departments within Zentiva manufacturing sites, corporate functions, affiliates and shared services\nExternal\nCommunication with External suppliers.","description_format":"text","description_chars":9294,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-09-23T03:36:38Z"}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":50,"reasons":["conf:2","win:early"],"computed_at":"2026-09-23T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/zentiva-external-quality-management-supplier-compliance-manager","json_url":"https://alion.io/job/zentiva-external-quality-management-supplier-compliance-manager.json","meta":{"generated_at":"2026-09-23T18:09:43Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}