Principal Compliance Consultant – Data Integrity

🕒 Junho 3

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

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Parexel

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1983

⚕️ Seguro de Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 Venture Round em 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel é uma das maiores organizações de pesquisa clínica (CROs) do mundo, oferecendo serviços abrangentes para o processo de desenvolvimento clínico das Fases I a IV. A empresa é especializada em gestão de portfólio, gestão de ensaios clínicos, estratégia regulatória, acesso ao mercado e gestão do ciclo de vida para biofarmacêuticos. A Parexel busca acelerar a chegada de medicamentos que transformam vidas ao mercado, alavancando sua expertise clínica, regulatória e terapêutica. Com uma equipe global de mais de 21. 000 profissionais, a Parexel trabalha para integrar insights de pacientes e desenhos de estudo inovadores a fim de desenvolver tratamentos em áreas terapêuticas como oncologia, neurociência, doenças raras, entre outras. Seu foco está na condução de ensaios clínicos eficientes e centrados no paciente.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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