{"id":7761,"date":"2026-03-17T20:00:31","date_gmt":"2026-03-17T20:00:31","guid":{"rendered":"https:\/\/jobs.dataaxisnode.com\/zambia\/job\/factory-manager-at-skyrock-labour-consultants\/"},"modified":"2026-03-20T00:14:07","modified_gmt":"2026-03-20T00:14:07","slug":"factory-manager-at-skyrock-labour-consultants","status":"expired","type":"job_listing","link":"https:\/\/jobs.dataaxisnode.com\/zambia\/?post_type=job_listing&p=7761","title":{"rendered":"Factory Manager at Skyrock Labour Consultants"},"content":{"rendered":"<p>Job Opportunity \u2013 Factory Manager Healthcare SectorJob board platform<br \/>\nOur Client is looking for a Factory Manager to lead the setup of a medical device manufacturing facility (Rapid Diagnostic Tests).<br \/>\nKey Responsibilities:<br \/>\nRegulatory Compliance and Readiness<br \/>\nLead the development and implementation of the QMS aligned with ISO 13485 and GMP requirements.<br \/>\nDefine regulatory strategy for upcoming RDT product registrations, submissions, and inspections; prepare documentation plans and timelines.<br \/>\nEstablish regulatory milestones, gap analyses, and readiness checklists for audits, inspections, and supplier qualifications.<br \/>\nLiaise with regulatory bodies, notified bodies, and consultants to secure guidance and alignment.<br \/>\nSOP Development and Documentation<br \/>\nCreate, validate, and maintain SOPs covering quality, regulatory, manufacturing, supplier management, and site operations.<br \/>\nDevelop work instructions, process maps, and record-keeping templates to support compliant product development and eventual manufacturing.<br \/>\nImplement robust document control practices, versioning, and audit trails to ensure audit readiness.<br \/>\nQuality Management System Implementation<br \/>\nDesign and roll out core QMS processes (document control, CAPA, changes, deviations, training, supplier quality, internal audits).<br \/>\nEstablish quality metrics and dashboards; implement CAPA systems with timely closure and effectiveness verification.<br \/>\nDefine product release criteria, qualification\/validation plans, and risk-based decision-making processes.<br \/>\nStakeholder Management and Governance<br \/>\nEstablish governance structures (steering committees, cross-functional workstreams) to align regulatory, quality, operations and finance.<br \/>\nManage expectations with internal leadership, external partners, suppliers, and regulatory consultants.<br \/>\nPrepare and deliver regular status updates, risk disclosures, and milestone reporting to senior management.<br \/>\nResource and Capacity Planning<br \/>\nAssess and organize initial resource needs (personnel, equipment, facilities, and budget) for readiness activities.<br \/>\nDevelop a recruitment, onboarding, and training plan focused on quality systems, regulatory requirements, and GMP hygiene.<br \/>\nDefine contingency plans and scalable staffing models for the transition to production.<br \/>\nRisk Management and Compliance Assurance<br \/>\nImplement risk assessment methods to identify regulatory, quality, and operational risks; establish mitigations and monitoring.<br \/>\nLead change control processes for process, equipment, and documentation that could impact regulatory compliance.<br \/>\nDevelop risk-based supplier qualification and auditing plans to ensure material quality and integrity.<br \/>\nProcess Development and Transfer Readiness<br \/>\nCarry out research to translate product concepts into manufacturing-ready processes; define process validation strategy aligned with regulatory expectations.<br \/>\nEstablish pre-production\/ pilot plans, sampling strategies, and data collection protocols to support future scale-up.<br \/>\nCreate line-of-sight plans for product transfer from development to manufacturing, including documentation and traceability requirements.<br \/>\nTraining and Culture Building<br \/>\nDevelop a comprehensive training curriculum on QMS, regulatory requirements, quality practices, and basic manufacturing controls.<br \/>\nFoster a culture of quality, compliance, transparency, and proactive risk reporting.<br \/>\nDocumentation and Audit Readiness<br \/>\nCompile and maintain essential documentation for internal readiness reviews and external audits.<br \/>\nPrepare for and coordinate anticipated regulatory inspections and third-party audits.<br \/>\nHealth, Safety, and Environmental Foundations<br \/>\nEstablish initial HSE policies and training aligned with local regulations and global best practices to ensure a safe setting for readiness activities.<br \/>\nProgram Management and Milestone Tracking<br \/>\nDefine and manage project plans with clear milestones, owners, and success criteria for regulatory and quality milestones.<br \/>\nIdentify interdependencies across functions and manage cross-functional risks and timelines.<br \/>\nSkills Requirement<br \/>\nKnowledge of GMP and ISO 13485<br \/>\nExperience building or implementing a QMS<br \/>\nFamiliar with regulatory submissions and inspections (ZMRA knowledge a plus)<br \/>\n-Proficient at writing and updating SOPs and work instructions<br \/>\n\u2013Strong document control and audit-trail practices<br \/>\nAbility to manage cross\u2011functional tasks with clear milestones<br \/>\nStrong communication with regulators, suppliers, and teams<br \/>\nBasic risk management (FMEA) and CAPA understanding<br \/>\nChange control and supplier qualification awareness<br \/>\nExperience in process development\/validation (IQ\/OQ\/PQ)<br \/>\nPlanning for readiness activities and early-stage production<br \/>\n-Ability to plan resources, budget, and timelines for setup<br \/>\n-Comfortable using ERP\/QMS software and basic data reporting<br \/>\n-Leadership readiness for a small, growing team; collaborative mindset<br \/>\nQualifications<br \/>\n\u00b7 Education: Bachelor\u2019s degree in Biomedicine, Pharmacy, Medical Laboratory Science, Biomedical Engineering, or a closely related field. Master\u2019s degree or MBA is a plus.<br \/>\n\u00b7 Experience: Minimum 5 years of manufacturing leadership or regulatory\/compliance experience in medical devices, diagnostics, or related sectors; experience with RDTs preferred. Prior exposure to startup or early-stage facility setup is advantageous.<br \/>\n\u00b7 Regulatory Knowledge: Understanding of GMP, ISO 13485; familiarity with local regulatory expectations (ZMRA) and potential regional requirements; exposure to CE\/FDA pathways is a plus if planning exports.<br \/>\n\u00b7 Quality &amp; Process: Experience with QMS implementation, CAPA, change control, risk management, and process validation (IQ\/OQ\/PQ).<br \/>\n\u00b7 Operations: Basic knowledge of production planning, capacity management, equipment qualification, and EHS compliance; readiness-focused mindset.<br \/>\n\u00b7 Data\/Technology: Comfort with ERP systems (e.g., SAP, Oracle), MES\/LIMS, document control software; ability to build basic data dashboards.<br \/>\n\u00b7 Leadership: Demonstrated ability to lead cross-functional teams, manage stakeholders, and influence without formal authority.<br \/>\n\u00b7 Communication: Strong written and verbal communication; ability to engage with regulators, suppliers, and internal teams.<br \/>\n\u00b7 Problem-Solving: Structured, data-driven approach to risk identification and mitigation.<br \/>\nSharing is Caring! Click on the Icons Below and Share<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"http:\/\/skyrocklabourconsultants@gmail.com","_company_name":"Skyrock Labour Consultants","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[11],"job-types":[12],"class_list":{"0":"post-7761","1":"job_listing","2":"type-job_listing","3":"status-expired","4":"hentry","5":"job_listing_region-zambia","7":"job-type-full-time"},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/zambia\/wp-json\/wp\/v2\/job-listings\/7761","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/zambia\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/zambia\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/zambia\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/zambia\/wp-json\/wp\/v2\/media?parent=7761"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/zambia\/wp-json\/wp\/v2\/job_listing_region?post=7761"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/zambia\/wp-json\/wp\/v2\/job-types?post=7761"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}