Save Job Back to Search Job Description Summary Similar JobsJoin a leading EU-GMP certified pharmaceutical manufacturerTake on a highly influential leadership role overseeing end-to-end QuaAbout Our ClientOur client is a recognized pharmaceutical organization with a long-standing presence in VietnamJob DescriptionLead and manage teams across Quality Operations, Quality Systems, and Compliance, ensuring effective QA oversight for the site.Monitor the implementation and performance of quality systems to maintain alignment with regulatory requirements and internal quality standards.Develop, implement, and manage Quality Assurance strategies to ensure full compliance with GMP, GLP, and applicable regulatory guidelines (DAV/EU/WHO/ICH).Provide technical support for GMP and overall Quality activities within manufacturing operations.Review and approve essential quality documents, including Site Master Files, Validation Master Plans, Quality Manuals, SOPs, and operational documentation to ensure cGMP compliance.Ensure timely review and approval of batch records, validation protocols, and related quality documentation.Lead investigations into product quality issues and oversee the implementation of corrective and preventive actions (CAPA).Review and approve major deviations, non-conformance reports, and related investigations.Manage key QA systems such as document control, deviation management, change control, CAPA, and risk management.Lead internal audits and support preparation for external audits and regulatory inspections.Support senior quality leadership during global and local inspections across various markets.Collaborate with cross-functional teams to maintain compliance and ensure seamless operations.Drive continuous improvement initiatives focused on enhancing quality systems and operational processes.Compile and analyze QA metrics for monthly operational and quality review meetings.Oversee training, team management, and development to foster a culture of quality and excellence.Manage QA budgeting, resource planning, and improvement projects.Participate in Quality Council meetings to discuss compliance status, share best practices, and support system enhancements.Utilize digital quality platforms such as electronic quality systems, electronic document management systems, and enterprise tools (e.g., SAP/LIMS) to optimize processes.Support compliance, regulatory activities, and additional responsibilities as assigned by site quality leadership.The Successful Applicant15+ years' experience in QA within pharmaceutical manufacturing, including at least 5 years in leadership roles.Background in USFDA/EU-approved facilities or multinational pharma organizations.Extensive experience managing large QA teams within dosage forms, including solids and sterile injectables.Strong knowledge of GMP/GLP, stability guidelines (ICH/WHO/EU)Familiarity with digital systems such as LIMS, SAP, and Electronic Quality Systems.Strong leadership, decision-making, problem-solving, and communication skills.What's on OfferOpportunity to lead the QA function at one of Vietnam's top EU-GMP certified pharmaceutical sites.Competitive compensation and benefits, along with relocation support.A collaborative, people-centric working culture focused on long-term development and continuous improvement.Career growth within a fast-expanding organization serving EU, SEA, and emerging markets.ContactTien GiangQuote job refJN-022026-6946121Job summaryFunctionEngineering & ManufacturingSpecialisationQuality, TechnicalWhat is your area of specialisation?Healthcare / PharmaceuticalLocationVietnamContract TypePermanentConsultant nameTien GiangJob ReferenceJN-022026-6946121