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Director of Regulatory QA Job Opening In Columbia – Now Hiring Eurofins

Director of Regulatory QA

    United States Jobs Expertini Expertini › United States › Jobs › Columbia › Operations Specialties Managers › Director Of Regulatory Qa

Job description

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

  • 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.

    Qualifications

    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

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

    Required Skill Profession

    Operations Specialties Managers


    • Job Details

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