Description

The Manager of Quality Assurance is responsible for providing quality assurance leadership and guidance throughout the DPT network of laboratories. Under the direction of the Director of Regulatory Affairs and Quality Assurance, this position, in tandem with RA/QA Management and Senior Operations Management, will assist with ensuring that DPT’s laboratories are inspection-ready at all times, compliant with regulations, and adhering to company lab programs. This position works closely and collaboratively with the other functional areas throughout the network of laboratories.

Routine Department Operations and Quality Assurance Focus:

• Manages assigned personnel activities within the RA/QA department (e.g., timecards, time off); collaborate with Director RA/QA in employee performance evaluations.
• Coaches, reviews, manages, and terminates assigned staff. Sets goals for assigned employees.
• Counsels assigned Quality Systems Specialists regarding problems / issues encountered in daily activities.
• Identifies continuous improvement opportunities and coordinate actions to improve processes; proactively manage critical issues of a quality nature. Identifies, coordinates and/or implements tools and process improvements to promote efficiency and process improvements through the organization.
• Creates and maintains relationships with other managers within the Eurofins DPT network that is productive and promotes teamwork and change.
• Consults on quality-related questions and issues from internal and external clients.
• Supports the company and department in meeting its goals and initiatives.
• Serves as a liaison for the organization to outside vendors, clients and auditors.
• Performs duties in compliance with all applicable regulatory and accrediting agencies.
• Supports the Director of RA/QA in
  • Executing organizational and department initiatives
  • Preparing materials as requested by Executive Management (trending data, Management Review, customer-specific meetings)
• Provides perspective and Subject Matter Expertise on the interpretation of Clinical Laboratory Regulatory requirements that impact the Company’s operations and regulatory compliance.
• Provides Quality Management support for QMS-related activities across our network of laboratories.
• Assists in designing and developing overall corporate quality system.
• Reviews and approves quality event investigations (including corrective action plans) to ensure thorough and high-quality records.
• Ensures laboratory practices are aligned and consistent across the organization, taking best practices into account helping to maintain audit-readiness throughout the organization, preparing laboratories for key inspections as well as internal and external audits.
• Oversees that new actions implemented as a result of customer complaints or deviations are to be rolled out to all laboratories.
• Trends Quality Management System timeline through the lifecycle of items (deviations, complaints, corrected reports, SCARs, CAPAs, etc.) for Operations Senior Management.
• Oversees training policies and procedures to ensure compliance with regulations and standards.
• Performs duties and tasks in a timely and compliant manner, ensuring accurate documentation and conclusions.
• Represents Eurofins DPT for client and regulatory-based audits/inspections.

Qualifications

TRAVEL REQUIREMENTS

• 5-15% travel to DPT locations, based on organizational need.
• Ability to meet STAT travel requests to host 2-5 unplanned regulatory audits annually.

MINIMUM REQUIREMENTS

• Bachelor of Science degree in a medical-related field; Medical Technologist license is strongly preferred.
• 15+ years laboratory operations experience.
• 5+ years auditing experience.

WORK EXPERIENCE REQUIREMENTS

• Technical knowledge of CLIA/CAP/FDA/OPTN laboratory regulations.
• Significant bench testing experience.
• Solid experience with QA programs, root cause analysis and implementation of actions.

POTENTIAL ENVIRONMENTAL FACTORS

• All laboratories carefully maintain 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.

Additional Info

Compensation:

• $100,000-$120,000

Schedule:

• Monday - Friday 8:00am - 4:30pm

What we offer:

• 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

Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.

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.