Associate Director Quality Assurance

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.

The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Position Summary:

This position will reside on site at a Eurofins US Food laboratory. The Associate Director of Quality Assurance will be responsible for supporting Quality team members as well as operational and technical supervisors and leads in all aspects of the Quality Management System. The role will also ensure timelines and quality measures are met and technicians are following SOPs. This position may have authority over local quality specialist(s) for delegated quality tasks.

• Demonstrates and promotes the company vision, mission, and quality objectives
• Regular attendance and punctuality, active participation and contributions
• Applies GMP/GLP in all areas of responsibility, as appropriate
• Reads, understands, and follows management system requirements as relevant to responsibilities. Fully familiar with Quality Manual, policies, procedures, work instructions and methods. ISO/IEC 17025 requirements and relevant government and FDA regulatory requirements. Including but not limited to 21 CFR Part 11, 58, 111, 117, 210, 211.
• Maintains ISO certification activities for all sites in the region. This includes, but is not limited to assisting and advising the laboratory staff with audit scheduling and execution, scope changes, and routine communication with the accreditation body.
• Reviews/Approves and ensures implementation of new/revised controlled documents
• Acts as a management resource for laboratory personnel and local quality responsible for correct application and interpretation of internal quality documents.
• Ensures implementation of corporate quality initiatives and provides updates on progress
• Provides leadership and actively accepts quality improvement projects of universal benefits to Eurofins based on understanding of potential opportunities
• Conducts or oversees annual (or per site SOP) assessment of all laboratories within their jurisdiction, provides constructive feedback with a detailed report when necessary.
• Regularly monitors metrics such as non-conformances, derogations, deviations and complaints for trends. Assists with root cause analysis and CAPA as necessary.
• Responsible for oversite of the PT program within the sites
• Responsible for ensuring the laboratories are on time with monthly metric reporting requirements to group.
• Answers client service customer inquiries related to quality matters when escalated.
• Participates, if necessary, in quality audits by clients or regulatory authorities. Ensures follow up actions are appropriate if required.
• Maintain…