Company 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.
Job Description
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 Management
Drive Predictive Quality Management through Data Analysis
- Utilize quality dashboard analytics to:
- Identify emerging quality risks and recurring issues.
- Monitor quality KPIs and performance trends.
- Predict potential quality deterioration.
- Drive proactive investigations and corrective actions.
- Provide data-driven insights to support continuous improvement and risk reduction.
6. Corrective and Preventive Action Management
- Lead and oversee the CAPA process arising from audits, crosschecks, claims, alerts, customer complaints, and client feedback.
- Ensure timely root cause analysis, implementation, and closure of corrective and preventive actions.
- Verify CAPA effectiveness and monitor sustainability of improvements.
- Escalate overdue, ineffective, or high-risk CAPAs to management.
- Drive systemic improvements to eliminate recurring issues and strengthen quality performance.
- Monitor CAPA trends and provide regular reports on status, effectiveness, and key risk areas.
7. Training and Quality Awareness
- Lead the development and implementation of quality awareness, competency development and continuous improvement programs.
- Collaborate closely with O5 Technical Management personnel to align quality standards, technical requirements, best practices, and customer expectations across all operations.
- Identify training and development needs through analysis of audits, quality incidents, CAPA findings, crosschecks, and KPI trends.
- Promote a culture of quality, compliance, accountability, and continuous improvement throughout the organization.
- Evaluate training effectiveness and drive ongoing workforce competency development.
8. Authority
The O5 Country Quality Manager is authorized to:
- Conduct announced and unannounced quality audits, crosschecks, and investigations across O5 operations.
- Request information, records, evidence, and corrective action plans related to quality, integrity, and compliance matters.
- Require Country Operations, Team Leaders, Technical Supervisors, and relevant stakeholders to implement corrective and preventive actions within agreed timelines.
- Escalate significant quality, integrity, compliance, or customer risks directly to Global Quality & Integrity Management, Country Cluster Management, and O5 Program Management.
- Recommend additional audits, crosschecks, training, process improvements, or operational controls where quality risks are identified.
- Recommend suspension of inspectors, approval authorities, suppliers, or operational activities when serious quality or integrity concerns are identified, subject to management approval.
- Escalate unresolved, overdue, or ineffective corrective actions to the appropriate management level.
Reporting Line
Direct Reporting:
- Global Quality & Integrity Manager, Country Cluster Manager, and O5 Program Management
Functional Collaboration:
- Country O5 Team Leaders
- O5 Technical Management
- Technical Supervisors
- O5 QA/ QC
- O5 Country Back Office Team
Key Performance Indicators (KPIs)
The O5 Country Quality Manager will be measured on:
- Completion of planned audits (%)
- Closure rate of audit findings and CAPAs
- Reduction in claim and alert rates
- Report accuracy and consistency levels
- Crosscheck effectiveness
- Integrity compliance rate
- Timeliness of quality reporting
- Dashboard utilization and risk detection effectiveness
- Overall country quality performance improvement
Qualifications
Candidate Profile
Education
- Bachelor's degree in Quality Management, Engineering, Business, Supply Chain, or related discipline.
Experience
- Minimum 5 years of experience in quality management, auditing, inspection, or compliance functions.
- Experience within inspection, testing, certification, sourcing, or manufacturing industries preferred.
- Strong knowledge of quality assurance systems and audit methodologies.
Competencies
- Independent and objective judgment
- Strong analytical and investigative skills
- Data analysis and dashboard reporting capability
- Root cause analysis and CAPA management
- Excellent communication and stakeholder management skills
- High level of integrity and professional ethics
Additional Information
Why Join Eurofins?
- Opportunity to work in a leading global laboratory and life sciences company.
- Exposure to regional finance operations and international stakeholders.
- Dynamic, professional, and collaborative working environment.
- Clear career development opportunities within finance and controlling functions.
- Competitive compensation and comprehensive employee benefits package.