Manager, GLP Quality Assurance - EAG Laboratories

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.

Job Description

The GLP Quality Assurance Manager together with operations plans, coordinates, and maintains Quality Assurance in compliance with all policies, procedures, customer specifications, and regulatory requirements. The GLP Quality Program Manager will work collaboratively with the laboratory management team to establish, improve, and monitor and enforce compliance to GLP requirements. The GLP Quality Program Manager will oversee all aspects of the GLP program. This position is a leadership role, and as such is expected to inspire employees to greater levels of professionalism, quality, productivity, and engagement with the team. Support and implementation of a Culture of Quality is paramount.

Essential Job Functions:

• Works closely with operations to ensure policies, procedures, customer requirements, local, state, and federal regulations are followed, and the operations are following GLP requirements at all times.
• Ensures escalation of non-conformance events to the proper operations and corporate QA personnel
• Oversees all quality aspects of GLP work in St. Louis. Required to review all study documentation including, method development reports, final reports and all other records ensuring compliance with regulations and customer requirements.   
• Ensures validation and calibration of all essential lab equipment. Reviews calibration records for compliance.
• Completes training as needed on GLP requirements.

Customer Specification Management

• Works closely with the Study Director to ensure customer requirements are captured properly, and protocols are written in compliance with GLP requirements as needed.
• Works with operations to resolve any customer concerns or complaints.

Standardized Operating Procedures (SOP’s)

• Authoring quality documentation including SOPs, Work Instructions, Report Templates etc. ensuring they are up to date, accessible to employees, and employees are trained on them with the training documented appropriately.
• Maintain controlled regulated documents, such as Study Methods, Deviations, Validations, Corrective/ Preventive Actions, and Change Controls.

Auditing

• Performs in process audits of studies and documents them appropriately.
• Schedules and accommodates customer audits as requested, responding to any findings in a timely manner.
• Hosts and leads regulatory audits including FDA, DEA, or any other regulatory audits requested.
• Conducts facility inspections to monitor lab activities and ensure compliance with SOPs.

Customer Complaints/Deviations

• Documents all Deviations and works with customers and operations to resolve them.
• Documents all Corrective/Preventive actions, ensuring on time closure, customer communication and customer satisfaction with the actions taken.
• Provides written reports to Director of Quality and Compliance as requested.
• Identifies any quality issues and reports them for correction immediately.
• Protects company and customer confidential information as well as proprietary processes.

Qualifications

Education, Skills and Experience:

• 5+ years of specifically