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

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 regulatory compliance.
• Provide Quality Management support for QMS-related activities across our network of laboratories.
• Assists in designing and developing overall corporate quality system.
• Establishes, monitors and/or modifies quality metrics to monitor the performance and state of control of the QMS; assist in dissemination of quality monitoring activities.
• Creates and revises quality and regulatory related SOPs to ensure compliance with applicable regulatory authorities.
• Reviews and approves quality event investigations (including corrective action plans) to ensure thorough and high-quality records.

Regulatory Affairs Oversight

• Maintain a strong working knowledge of applicable regulatory guidelines for agencies including, but not limited to, FDA, CLIA, TGA, GHA, ISO 15189, ASHI, and CAP.
• Promote and ensure regulatory inspection readiness activities.

• Hosts and guides quality audits and inspections from clients and other external regulatory agencies; supports client and regulatory audits/inspections in a remote capacity, when necessary.
• Compiles and /or reviews client and Regulatory audit responses to ensure our commitments. meet quality and regulatory expectations; drives timely corrective actions for those findings.
• Verifies the accuracy and current state of licenses, registrations, and other regulatory submissions; assist in performing those submissions, as needed.
• Identifies Quality System-related training needs; facilitates the delivery of that training.

Leadership

• Supports Eurofins DPT’s business philosophy, leadership values and ethics.
• In order to meet Eurofins DPT’s quality policy and objectives, all employees are expected to meet basic expectations of Eurofins DPT’s quality management system including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, and accurate recordkeeping.
• As a partner to the Operations team, defines the best tactical direction for Quality Management. initiatives & ensures compliance and alignment to company mission, values, and business goals.
• Be a team player, develop and maintain excellent working relations within the organization.
• Demonstrates a high level of team management and empowerment and possess the ability to perform to the requirements.
• Enthusiastic, self-motivated person with great communication skills who can support regulatory compliance and quality management for the company.
• Demonstrates a high level of team management and empowerment and possess the ability to perform to the requirements.

Minimum Educational Requirements: 

• Bachelor’s Degree in a Science-related field; advanced degree preferred.

Basic Minimum Qualifications :

• Minimum 10 years of quality experience within the clinical laboratory industry.
• Minimum5 years of technical laboratory experience in a regulated environment is also preferred.
• Minimum 5 years of experience with regulatory and/or accrediting agencies (e.g., FDA, ISO, ASHI, CLIA, CAP) hosting/performing inspections, responses to regulators, etc.
• Quality certification highly desired (e.g., ASQ-CQA, ASQ-CQM/OE).
• Technical knowledge of regulatory requirements, including but not limited to FDA, CLIA, CAP, ASHI, ISO.
• Ability to interpret and apply government and industry regulations.
• Experience in the preparation and filing of regulatory submissions for Clinical laboratory operations.
• Ability to analyze, define and effectively convey difficult and complex issues in a way that accurately communicates the issues to leadership and external business partners.
• Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills.
• High level of initiative and excellent collaboration skills to facilitate cross-functional projects.
• Ability to problem solve and make decisions on complex issues, often in a cross-functional team setting.
• Strong organizational and planning skills as well as strong attention to detail.
• Ability to work independently with limited supervision, adapt to change and manager multiple tasks.
• Project a positive, professional demeanor at all times.
• This position will require periodic travel within the US.
• Authorization to work in the United States indefinitely without restriction or sponsorship

Potential Environmental Factors:

• This laboratory carefully maintains all hazardous materials.  All employees must abide by Eurofins DPT’s Safety and Exposure procedures.  This includes using the provided safety clothing and equipment.
• For a list of potential chemical hazards, see appropriate SDS sheet.

Position is full time working Monday - Friday, 8:00 am - 5:00 pm, with overtime as needed.  Candidates currently living within a commutable distance of Centennial, CO are encouraged to apply.

• Salary: $110,000 - $150,000
• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Please be aware that this role will require access to a site that requires COVID-19 vaccination or exemption from vaccination requirements. Prior to starting work in this position, employees must show proof of full Covid-19 vaccination or exemption from vaccination requirements. Exemptions will be granted as warranted by medical contraindications, disability or sincerely held religious beliefs.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.