Principal Compliance Consultant – Data Integrity

🕒 June 3

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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