Parexel

Parexel

Principal Compliance Consultant (Former FDA ORA/OMQ Experience Preferred)

United States - Remote · Principal

Sponsorship not specified$50k-$70kDetected 30 days ago
Business DevelopmentClinical TrialsPublic HealthGMPFDA RegulatoryLeadershipCommunicationMentoringRegulatory Affairs

About the role

  • From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
  • Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.
  • We take our work personally, we do it with empathy and we're committed to making a difference.

Responsibilities

  • Lead inspection readiness and mock inspection programs, helping clients prepare with confidence
  • Advise on and support response strategies for:
  • Collaborate across cross-functional teams to support complex quality and regulatory engagements
  • Mentor team members and contribute to building internal expertise
  • Developing Import Alert recommendations
  • Partner with organizations to resolve complex issues rather than only documenting them

Requirements

  • Prior experience with the U.S. Food and Drug Administration in inspection, compliance, or enforcement roles
  • Strong understanding of GMP compliance and pharmaceutical manufacturing systems
  • Ability to translate regulatory expectations into clear, actionable solutions for clients
  • Ability to travel 50-70% with a focus on international travel
  • 15+ years of related experience, including significant FDA experience in inspection, compliance, or enforcement roles
  • Experience Required

Nice to have

  • Preferred Technical Expertise
  • Advanced degree preferred (e.g., MPH, MS, PhD, MBA)

Compensation

  • $50k-$70k

Equal opportunity

  • EEO Disclaimer
  • equal opportunity employer.
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This listing is sourced directly from Parexel's careers page and normalized into a canonical job model.