Principal Compliance Consultant – Data Integrity

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a senior consultant to clients regarding FDA regulatory standards, inspection strategies, and compliance risk reduction.

• Oversee inspection readiness and mock inspection initiatives, enabling clients to prepare confidently.

• Utilize extensive FDA experience to foresee inspection outcomes and proactively tackle potential gaps.

• Provide guidance and support for response strategies related to: Form FDA 483 observations, Warning letters, Import alerts, Regulatory meetings, Consent decrees, and enforcement actions.

• Assist clients in conducting root cause analysis, developing remediation plans, and implementing sustainable compliance solutions.

• Offer expertise in risk-based decision-making, including regulatory discretion and ensuring supply continuity.

• Collaborate with cross-functional teams to facilitate intricate quality and regulatory projects.

• Mentor junior team members and help cultivate internal expertise.

• Participate in client discussions and aid in business development initiatives.

⛳️ Requirements

• A demonstrated history of experience at the FDA within the Office of Regulatory Affairs (ORA), Office of Inspections and Investigations (OII), and/or Office of Compliance (CDER).

• Proven leadership in both domestic and international GMP inspections, including assignments abroad.

• Experience in conducting for-cause, pre-approval, and surveillance inspections.

• Participation in high-priority or complex inspection scenarios.

• Direct involvement in supporting regulatory enforcement actions, including:

• - Drafting or contributing to Warning Letters.

• - Developing recommendations for Import Alerts.

• - Participating in recalls, regulatory meetings, or enforcement escalations.

• Interaction with industry regarding compliance expectations and post-inspection follow-up.

• Experience with Data Integrity inspections and remediation efforts.

• Knowledge of sterile manufacturing and aseptic processing.

• Familiarity with API and drug product manufacturing across various dosage forms.

• Capability to translate regulatory expectations into clear, actionable strategies for clients.

• Excellent communication and stakeholder engagement abilities.

• Willingness to travel 50-70%, with a particular emphasis on international travel.

🏝️ Benefits

• Opportunity to transition from enforcement to influence, assisting organizations in proactively meeting regulatory standards.

• Experience with complex and high-impact challenges across global life sciences clients.

• Collaborative consulting environment that offers leadership and mentorship opportunities.

• Direct involvement in enhancing product quality, compliance, and patient safety.