Director of Regulatory QA

Job 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.

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

• Provide strategic leadership to managers overseeing Quality Assurance, Quality Engineering, Metrology, Document Control, and Training.
• Ensure alignment of departmental goals with organizational objectives and regulatory expectations.
• Mentor and develop managerial staff to foster leadership growth and operational excellence.
• Promote cross-functional collaboration and accountability across quality and regulatory teams.

Quality Assurance & Quality Engineering

• Guide the development and maintenance of the Quality Management System (QMS).
• Ensure compliance with cGMP, GLP, and GCP standards across all testing and manufacturing activities.
• Oversee audit readiness, CAPA programs, deviation investigations, and change control processes.
• Drive continuous improvement initiatives and risk-based quality strategies.

Metrology & Equipment Qualification

• Ensure proper calibration, maintenance, and qualification of laboratory and manufacturing equipment.
• Oversee metrology systems to meet regulatory and operational requirements.
• Collaborate with engineering and validation teams to support equipment lifecycle management.

Training & Compliance

• Oversee the development and execution of a comprehensive training program to ensure staff competency and regulatory readiness.
• Monitor training effectiveness and compliance across departments.
• Foster a culture of quality, accountability, and continuous learning.

Strategic Leadership & Client Engagement

• Partner with business development and operations to support client onboarding, audits, and project execution.
• Provide regulatory and quality guidance during proposal development and project planning.

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

Education & Experience

• Bachelor's or advanced degree in Life Sciences, Pharmacy, Engineering, or related field.
• Minimum 10 years of experience in FDA-regulated industries (pharmaceutical, biotech, or CRO).
• Prefer at least 3 years in a senior leadership role overseeing regulatory or quality functions.
• Experience managing managers and cross-functional teams.
• Proven track record in building and leading high-performing teams.

Skills & Attributes

• Deep knowledge of FDA, EMA, ICH, and other global regulatory frameworks.
• Expertise in GMP, GLP, GCP, and ISO standards.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication, technical writing, and presentation abilities.
• Proficiency in QMS, ERP systems, and Microsoft Office Suite.
• Ability to manage multiple priorities in a deadline-driven environment.

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:

• Comprehensive medical coverage, dental, and vision options.
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

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

Required Skill Profession

Operations Specialties Managers