Global Head of Quality Audit, External Liaison

🕒 6 days ago

🏖️ New Jersey, Massachusetts – Remote

🏖️ New Jersey – Remote 🍂 Massachusetts – Remote

💵 $247.5k - $357.5k / year

⏰ Full Time

🔴 Lead

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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

• Design, develop, and implement the department roadmap • Lead risk-based auditing strategies, tactics, and operations across GXP • Engage externally for intelligence, benchmarking, and advocacy on critical Sanofi topics • Lead regulatory inspection activities for routine and pre-approval inspections by international regulators • Support due diligence and reverse due diligence activities • Utilize data and technology to drive efficiencies, enhance insights, facilitate knowledge sharing, and simplify processes • Represent Sanofi externally at key industrial and trade association meetings and working groups • Foster a culture of quality and cGMP compliance across organizational levels to drive continuous improvement • Operate with high independence, thoughtful risk-taking, and a compliance mindset • Interface with Auditing and Compliance organizations across Sanofi

🎯 Requirements

• 15+ years of relevant experience in the pharmaceutical, biotech, medical device, or related industries, or a major regulatory authority • Strong experience with regulatory and pharmaceutical policy • Inclusive, transformational, pragmatic leadership and change management • Fluent English • Bachelor's degree in a related science required • Previous auditor experience, regulatory authority inspector interface, and/or regulation intelligence/advocacy experience is a plus • French-speaking ability is a plus

🏖️ Benefits

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

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