Principal Compliance Consultant – Data Integrity

🕒 il y a 22 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🔴 Expert

🚔 Conformité

🦅 Parrain de Visa H1B

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Parexel

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1983

⚕️ Assurance santé

🧬 Biotechnologie

💊 Pharmaceutique

💰 Venture Round en 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel est l'une des plus grandes organisations de recherche clinique (CRO) au monde, fournissant des services complets pour le processus de développement clinique de la Phase I à IV. L'entreprise se spécialise dans la gestion de portefeuille, la gestion des essais cliniques, la stratégie réglementaire, l'accès au marché et la gestion du cycle de vie des produits biopharmaceutiques. Parexel vise à accélérer la mise sur le marché de médicaments qui changent la vie en tirant parti de son expertise clinique, réglementaire et thérapeutique. Avec une équipe mondiale de plus de 21 000 professionnels, Parexel s'efforce d'intégrer les perspectives des patients et des conceptions d'essais innovantes pour développer des traitements dans des domaines thérapeutiques tels que l'oncologie, les neurosciences, les maladies rares et plus encore. Elle se concentre sur la fourniture d'essais cliniques centrés sur le patient et efficaces.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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