Director of Quality Assurance, CTS

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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It 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. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer 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 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Essential Duties and Responsibilities:

The primary responsibilities include but are not limited to the following:

• Provide leadership and direction within the Quality Assurance department, ensuring compliance with regulations, Standard Operating Procedures (SOPs), FDA GxP regulations, EMEA, and guidance documents (e.g., ICH) as applicable
• Manage, coordinate the review and approval of productions records, providing guidance for compliance to cGMP and company SOPs
• Oversee the training, development and growth of employees ensuring compliance of quality standards
• Facilitate the achievement of Quality Assurance operational objectives
• Ensure all appropriate licenses have been acquired and maintained for the business and are up to date
• Ensure all team members have completed their appropriate training before they are able to perform their job responsibilities
• Ensure Quality Control completes their material inspection and review in a timely manner as not to impact schedules or timelines
• Ensure Quality Assurance releases all materials to meet timelines as not to impact schedules and timelines
• Develop a DEA program for the CTS business unit including ARCOS reporting
• Ensure all DEA requirements are met and maintained
• Write, review, and approve SOPs, Controlled Forms, and other GMP documents
• Collaborate with the Operations and Quality Systems departments to identify and implement quality enhancements and resolve deviations
• Maintain quality standards to ensure continuous improvements in processes and systems departmentally and on a company level
• Responsible for the Quality Assurance team’s KPIs and creating new KPIs for continuous improvement
• Responsible for adequate resourcing of the Quality Assurance and Quality Control teams as well as performance reviews, goal setting, coaching, training, scheduling and other managerial responsibilities 
• Develop positive engagement with cross-functional department heads of CTS
• Work autonomously to deliver on KPI and objectives agreed upon with Vice President, Quality & Regulatory Affairs
• Assess current Quality Assurance standards and procedures to evaluate the effectiveness of the Quality Assurance program in order to determine areas of improvement to ensure compliance with regulatory requirements
• Ensure the Quality Assurance department is prepared for all level of audits
• Participate in client audits and regulatory agency inspections as well as formal responses to their findings/recommendations
• Provide training to site employees in FDA Inspection Readiness activities and regulatory guidelines (i.e. preparation and conduct during regulatory inspections).
• Ensure the appropriate level of resources and expertise is in place and that this is structured in the most effective way to deliver the strategy
• Provide quality and regulatory guidance to site personnel and directly on quality related issues
• Act as back-up/additional resource for Quality System review of validations, reports

Qualifications

To perform this job