Principal Compliance Consultant – Data Integrity
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Job Description
Principal Compliance Consultant leveraging FDA experience to drive compliance strategies and solutions for life sciences clients. Leading inspections, advising on regulations, and mentoring teams in a collaborative environment.
Responsibilities:
- 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
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