Director of Regulatory QA

Job Description

Job Description

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 Organization 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 Organizations. It also has a rapidly developing presence in highly specialized 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 decentralized 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.

Job Description

We are seeking a dynamic and experienced  Sr. Director / Director of Regulatory & Quality Assurance  to lead and oversee the strategic direction of our Quality Assurance, Quality Engineering, Metrology, Document Control and Training functions within a fast-paced pharmaceutical contract research organization (CRO).  This role is responsible for guiding a team of functional managers to ensure regulatory compliance, operational excellence, and client satisfaction across all phases of drug development and testing.

The ideal candidate will bring a strategic mindset, strong leadership capabilities, and a collaborative approach to drive continuous improvement and regulatory alignment across the organization. This is a high-impact role for a leader who thrives in a mission-driven, science-based environment.

Key Responsibilities

Regulatory Affairs Leadership

• Develop and maintain regulatory strategies, policies, and procedures to ensure compliance with FDA, EMA, ICH, and other global regulatory bodies.
• Oversee regulatory submissions in collaboration with clients and internal stakeholders.
• Ensure regulatory compliance in product labeling, advertising, and promotional materials.
• Serve as the primary liaison with regulatory agencies and clients on compliance matters.
• Support audits and inspections, including FDA, sponsor, and third-party audits.

Functional Oversight & Team Leadership

Quality Assurance & Quality Engineering

Metrology & Equipment Qualification

Training & Compliance

Strategic Leadership & Client Engagement

Contribute to strategy and client value proposition through quality and compliance excellence.

Qualifications

Education & Experience

Skills & Attributes

Additional Information

This position is a full-time role, Monday-Friday, 8 a.m.-5 : 00 p.m., with overtime as needed.  Candidates who live within a commutable distance from Columbia, MO are encouraged to apply.

Excellent full-time benefits including :

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.