Manager, Regulatory Affairs and Quality Assurance

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.

The Manager of Regulatory Affairs and Quality Assurance Department is responsible for providing regulatory and quality assurance leadership and guidance throughout the Eurofins DPT network of laboratories. Manager is responsible for day-to-day operational implementation of activities for Quality Assurance and Regulatory Compliance.  Responsibilities include the management of quality system activities, to include but may not be limited to: Quality Event Management, Change Management, Risk Management, Audits (both internal and external) quality planning and improvement, quality monitoring and reporting, and quality system training to promote the company and department in achieving its goals. Responsibilities also include Regulatory-related activities such as management and oversight of regulatory filings and submissions. This position works closely and collaboratively with the other functional areas throughout the network of laboratories

Job Description

Manager, Regulatory Affairs and Quality Assurance responsibilities include, but are not limited to, the following:

Routine Department Operation:

• Manages personnel activities within the RA/QA department (e.g., timecards, time off); collaborate with Director RA/QA in employee performance evaluations.
• Hires, coaches, reviews, manages and terminates staff. Sets goals for employees.
• Counsels RA/QA staff with regard to problems / issues encountered in daily activities.
• Identifies continuous improvement opportunities and coordinate actions) to improve processes; proactively manage critical issues of a quality nature.
• Contributes, manages, and executes effective, proactive quality and regulatory strategies and plans.
• Creates and maintains relationships with other managers within the Eurofins DPT network that is productive and promotes teamwork and change.
• Consultations on quality related questions and issues from internal and external clients.
• Supports the company and department in meeting its goals and initiatives.
• Identifies, coordinates and/or implements tools and process improvements to promote efficiency and process improvements throughout the organization.
• Serves as a liaison for the organization to outside vendors and clients.
• Assists in the development of a budget and monitors RA/QA department expenditures.
• Performs duties in compliance with all applicable regulatory and accrediting agencies.
• Facilitates the management and effectiveness of the document control and corporate training programs.
• Supports the Director of RA/QA in:
  1. executing organizational and department initiatives.
  2. Preparing materials as requested by Executive Management (trending data, Management Review, customer-specific meetings).
• Other duties as assigned.

Quality Assurance Oversight

• Provides perspective and Subject Matter Expertise on the interpretation of Clinical Laboratory Regulatory requirements that impact the Company’s operations and regulato