[HCM - Tan Phu] O5 Country Quality Manager

Eurofins Ho Chi Minh City, vn Full-time Updated 6 October 2026
PharmaBiotechCROMedTechQuality Assurancecroinform

Job description

Eurofins Scientific through its subsidiaries is a world leader in food, environment, pharmaceutical and cosmetic product testing, discovery pharmacology, forensics, advanced material sciences, and in agroscience Contract Research services. It is also one of the global independent market leaders in genomics and in the support of clinical studies, as well as in BioPharma Contract Development and Manufacturing. In addition, Eurofins is one of the key emerging players in specialty esoteric and molecular clinical diagnostic testing in Europe and the USA. With ca. 62,000 staff across a network of over 1,000 independent companies in 62 countries and operating over 900 laboratories, Eurofins offers a portfolio of over 200,000 analytical methods for evaluating the safety, identity, composition, authenticity, origin and purity of biological substances and products, as well as for innovative clinical diagnostics. The objective of Eurofins companies is to provide their customers with high-quality services, accurate results on time and expert advice by their highly qualified staff. Position Summary The O5 Country Quality Manager is responsible for leading the implementation, oversight, and continuous enhancement of the O5 Program Quality Control Framework within the assigned country. The role functions independently from day-to-day operational activities to ensure objectivity, integrity, and consistency across inspection processes, quality reporting, and compliance with O5 requirements. The O5 Country Quality Manager acts as the primary liaison among Country Operations , the Country Team Leader , and O5 stakeholders , with responsibility for identifying risks, monitoring quality performance, conducting audits, and driving corrective and preventive actions. To preserve independence and impartiality, the O5 Country Quality Manager operates separately from the local O5 operations team and reports directly to the Global Quality & Integrity Manager and the Country Cluster Manager . Key Responsibilities 1. O5 Program Quality Control & Audits Inspection Audits (Announced & Unannounced) Plan and conduct regular announced and unannounced audits of O5 inspection operations (e.g., Insitu & Crosscheck activities). Perform independent reviews of inspection execution, inspection reports, and operational practices. Assess compliance with: Customer requirements O5 operational procedures Quality and integrity standards Regional and global quality policies Document audit findings, identify risks, and areas for improvement, and issue audit reports. Ensure timely follow-up, implementation, and closure of audit findings and corrective actions. Crosschecks & Issue Management Review the results of issue audits, crosschecks, and quality investigations. Analyze recurring quality issues and identify root causes and trends. Monitor the implementation and effectiveness of Corrective and Preventive Actions (CAPAs). Escalate significant quality, integrity, or compliance risks to the Global Quality & Integrity Manager and O5 Program Management at Eurofins, as appropriate. Provide recommendations to prevent recurrence and strengthen quality performance. 2. KPI Monitoring and Quality Performance Management KPI Analysis Conduct monthly reviews of Country O5 KPI performance. Monitor and analyze key quality performance indicators, including: Claim rates Alert rates Report quality metrics Billing error rates Insitu and Crosscheck audit performance Identify trends, risks, and opportunities for improvement through data analysis. Investigate significant KPI deviations and recommend corrective actions. Provide regular quality performance reports and recommendations to country and global management. Quality Review Meetings Organize and facilitate regular quality review meetings with: Country Team Leaders Technical Supervisors O5 program technical management Country cluster managers Present and review quality performance results, audit outcomes, KPI trends, and ongoing improvement initiatives. Discuss key quality risks, recurring issues, and corrective action progress. Ensure accountability for agreed action plans, corrective actions, and quality improvement targets. Monitor the timely implementation and effectiveness of action items arising from review meetings. Escalate significant quality concerns, unresolved issues, or performance gaps to the appropriate management level when necessary. 3. Report Quality Control Report Review Program Develop, implement, fine-tuning and maintain a report review framework to ensure consistent report quality standards. Conduct random audits of inspection reports reviewed & approved by Team Leaders. Verify: Accuracy Completeness Consistency Compliance with client requirements and O5 reporting standards. Identify recurring reporting deficiencies, training needs, and process gaps. Monitor the effectiveness of corrective actions related to report quality issues. Provide feedback and recommendations to Team Leaders and QCs to improve report quality and consistency. Documentation Compliance Ensure the proper maintenance, retention, and accessibility of quality records, audit reports, and supporting documentation. Verify that adequate evidence is maintained to support quality decisions, audit findings, and corrective actions. Ensure documentation complies with O5 requirements, customer requirements, and applicable corporate policies. Monitor adherence to document control and record management procedures. 4. Integrity and Compliance Controls Integrity Protection Measures Implement and monitor and continuously improve integrity and compliance controls within the country operation. Oversee the deployment, completion, and compliance of: O5 Inspection Completion, Anti-Bribery & Integrity Declaration Form QC Declarations Quality and compliance records Other integrity verification and monitoring mechanisms. Verify the effectiveness of integrity controls and identify opportunities for enhancement. Promote awareness of ethical conduct, professional standards, and integrity expectations across the country organization. Risk Monitoring and Investigation Identify potential quality, integrity, and compliance risks through data analysis, audits, crosschecks, and trend monitoring. Conduct or support investigations into quality, integrity, compliance, or misconduct concerns. Ensure investigations are properly documented, evidence-based, and concluded in a timely manner. Monitor the implementation and effectiveness of corrective and preventive actions arising from investigations. Escalate significant integrity breaches, compliance violations, or high-risk findings to the Global Quality & Integrity Manager and relevant management as appropriate. Recommend and implement preventive measures to strengthen operational integrity and reduce recurring risks. 5. Quality Data Analytics & Dashboard Manag

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