Director of Regulatory QA at Eurofins USA BioPharma Services
Columbia, Missouri, USA -
Full Time


Start Date

Immediate

Expiry Date

07 Nov, 25

Salary

0.0

Posted On

08 Aug, 25

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Technical Writing, Iso Standards, Life Sciences, Ema, Overtime, Managing Managers, Gmp

Industry

Pharmaceuticals

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.

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.

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.
    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:

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

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