Principal Compliance Consultant – Data Integrity

ComplianceComplianceFull TimeRemoteLeadTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

16 days ago

Salary

0

Seniority

Lead

Bachelor Degree15 yrs expEnglish

Job Description

Principal Compliance Consultant – Data Integrity

Parexel

• Serve as a senior advisor to clients on FDA regulatory expectations, inspection strategy, and compliance risk mitigation • Lead inspection readiness and mock inspection programs, helping clients prepare with confidence • Apply firsthand FDA knowledge to anticipate inspection findings and proactively address gaps • Advise on and support response strategies for: Form FDA 483 observations, Warning letters, Import alerts, Regulatory meetings, Consent decrees and enforcement actions • Guide clients through root cause analysis, remediation planning, and sustainable compliance solutions • Provide expertise in risk-based decision-making, including regulatory discretion and supply continuity • Collaborate across cross-functional teams to support complex quality and regulatory engagements • Mentor team members and contribute to building internal expertise • Engage in client discussions and contribute to business development efforts

Job Requirements

  • A proven track record of experience working at the FDA in the Office of Regulatory Affairs (ORA), Office of Inspections and Investigations (OII), and/or Office of Compliance (CDER)
  • Leadership in domestic and international GMP inspections, including foreign cadre assignments
  • Experience conducting for-cause, pre-approval, and surveillance inspections
  • Involvement in high-priority or complex inspections
  • Direct experience supporting regulatory enforcement actions, including:
  • Drafting or contributing to Warning Letters
  • Developing Import Alert recommendations
  • Participating in recalls, regulatory meetings, or enforcement escalations
  • Engagement with industry on compliance expectations and post-inspection follow-up
  • Data Integrity inspections and remediation
  • Sterile manufacturing / aseptic processing
  • API and drug product manufacturing across multiple dosage forms
  • Ability to translate regulatory expectations into clear, actionable solutions for clients
  • Strong communication and stakeholder engagement skills
  • Ability to travel 50-70% with a focus on international travel

Benefits

  • Opportunity to move from enforcement to influence, helping organizations proactively meet regulatory expectations
  • Exposure to complex and high-impact challenges across global life sciences clients
  • Collaborative consulting environment with leadership and mentorship opportunities
  • The ability to directly contribute to improving product quality, compliance, and patient safety

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