Global Quality Auditor

🔥 8 minutes ago

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $133.5k - $192.8k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔎 Auditor

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Sanofi

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2004

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

💰 Post-IPO Equity on 2022-03

Healthcare • Manufacturing • Logistics

Sanofi is a global healthcare company focused on pharmaceutical innovations and improving people's lives through advancements in science. The company is deeply engaged in research and development across several medical fields, including immunology, neurology, oncology, rare diseases, and vaccines. Sanofi is also dedicated to consumer healthcare, with efforts to enhance physical and mental wellness, allergy care, and treatments for cough, cold, and flu. In addition, Sanofi employs artificial intelligence in its research efforts and emphasizes environmental sustainability, diversity, and inclusion as part of its social impact agenda. With a strong commitment to transforming healthcare for vulnerable communities and leading scientific collaborations worldwide, Sanofi plays a significant role in the pharmaceutical and healthcare industries.

📋 Description

• Ensure Sanofi Quality and Compliance Standards and applicable regulatory requirements are met • Conduct independent audits and follow up on findings • Act as lead auditor or co-auditor in accordance with Sanofi processes • Support qualification of new auditors • Conduct transversal assessments • Prepare, coach, and support entities for regulatory inspections, including unannounced or short-notice visits • Participate in external associations to stay current with emerging trends • Evaluate entity risks through targeted risk-based agendas and mitigation advice • Escalate critical issues and risks • Approve and manage CAPAs • Participate in Quality Governance Committees such as IRISC • Participate in audits and activities with Sanofi Quality Audit, Inspection, Intelligence & Advocacy teams • Contribute to departmental QMS, including training curricula, standard audit agendas, and controlled documents • Lead cross-functional teams for initiatives or projects as needed • Detect evolving trends and help adjust Sanofi audit and inspection strategy and tactics • Transform auditing practices across Sanofi • Cover Manufacturing & Supply, Research & Development, Country Offices, Digital, Global Quality organizations, and third parties

🎯 Requirements

• Bachelor’s degree in life sciences, pharmacy, engineering, or any field • 5+ years' experience in quality auditing, preferably within the pharmaceutical or biopharma industry • Strong track record in cGMP environments, regulatory inspection support, and risk-based audit methodologies • In-depth knowledge of international regulatory requirements and major health authorities including US FDA, EMA, ANSM, NMPA, PMDA, and ANVISA • Proficiency in audit methodologies, CAPA management, and risk assessment frameworks • Highly independent and self-directed, with a strong compliance mindset • Ability to think creatively while taking thoughtful, calculated risks • Demonstrated leadership capabilities and cross-functional collaboration skills • Willingness and ability to travel domestically and internationally, approximately 50% • Fluent written and spoken English • French-speaking preferred for Europe-based role • Excellent written and verbal communication skills • Strong analytical and problem-solving capabilities • Ability to detect evolving trends and leverage data and metrics to assess quality system effectiveness against governing requirements

🏖️ Benefits

• Opportunities for promotion or lateral career moves, at home or internationally • Thoughtful rewards package • High-quality healthcare • Prevention and wellness programs • At least 14 weeks’ gender-neutral parental leave • Cutting-edge technology, digital, data, and AI-driven innovation opportunities