Principal Compliance Consultant – Data Integrity

Role Overview

• 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

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