Quality Risk & Compliance Manager

Company Description

Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.

In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 47 countries, employing about 45.000 staff.

Eurofins stands for a conception of clinical diagnostics entirely focused on excellence, innovation and technological investment. Eurofins clinical diagnostics offers testing services in all medical specialties. 

As a central element in healthcare, clinical diagnostics contributes to every stage of patient care: predisposition, prevention, diagnostics, treatment monitoring and prognosis. 

With hundreds of thousands of clinical diagnostics tests performed every day, the laboratories of the clinical diagnostics division strive to ensure that every patient, wherever he or she lives, has access to the most specialized and most innovative techniques for diagnosis, monitoring and therapeutic adjustment. Our logistics expertise and our daily sample collection and delivery network, guarantee perfect continuity in the provision of care while ensuring the same standard of quality and access to innovation across all the regions we serve.

Job Description

This position is responsible for overseeing the functions and responsibilities related to organizational Quality Risk and Business Continuity. Responsibilities include the continual improvement/maintenance of those programs so that DPT may comply with applicable regulatory requirements and Eurofins-driven expectations. This position works closely with other functional areas throughout the network of laboratories as well as compliance counterparts in the Eurofins network, to provide perspective, interpretation, and guidance as Eurofins DPT’s Subject Matter Expert (SME).

Quality Risk & Compliance Manager responsibilities include, but are not limited to, the following:

• Develop, execute, manage, and revise effective, proactive Business Continuity and Quality Risk strategies and plans for the DPT network of laboratories.
• Participate, facilitate or organize teams to conduct Business Impact and Risk Analysis activities related to the systems & subsystems of DPT, including crisis response activities during business interruptions.
• Coordinate and conduct internal and/or external exercises, tests, audits or reviews of those systems/subsystems to ensure they are effective at meeting strategy objectives and emergency responses.
• Identify, coordinate &/or implement tools (including procedures and training) that are appropriate for risk-based activities within DPT’s network of laboratories.
• Develop and revise company policies and procedures to meet current and applicable laws, regulations, rules and organizational requirements.
• Support client and regulatory audits/inspections as the Quality Risk Management SME; promote regulatory inspection readiness.
• Perform QA review and disposition of qualification* records (plans/protocols, final reports, deviations) for compliance and accuracy in accordance with DPT’s Master Validation Plan and applicable Regulatory requirements.
  • This includes, but is not limited to: facility, equipment, software, interface, assay, client methodology, sterilization, etc.)
• Identify, coordinate, assist &/or implement QA activities that require qualification (including validation & verification).
• Establish, monitor and/or modify quality metrics to monitor the performance and state of control of the Quality Risk Management and Business Continuity programs; assist in the dissemination of those monitoring activities.
• Support the organization and these programs in meeting its goals and initiatives and maintaining those accomplishments.
• Create and maintain relationships with other managers within the DPT network, as well as the Eurofins US parent organization, that is collaborative, and productive and promotes teamwork and change.
• Other projects as assigned.
• In order to meet Eurofins DPT’s quality policy and objectives, all employees are expected to meet basic expectations of DPT’s quality management system including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation p