Global Quality Auditor

🔥 4 minutes ago

🇺🇸 United States – Remote

💵 $133.5k - $192.8k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔎 Auditor

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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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

• Cover all GxP audits in Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) • Act as lead auditor or co-auditor in accordance with Sanofi processes • Conduct transversal assessments • Contribute to team scheduling and review/approve audit reports for team members • Evaluate entity risks and develop targeted risk-based agendas or advise on mitigations • Escalate critical issues and risks • Approve and manage CAPAs • Perform due diligence assessments as needed • Participate in audits and activities with Sanofi Quality Audit, Inspection, Intelligence & Advocacy teams • Contribute to departmental QMS materials such as training curricula, standard audit agendas, and controlled documents • Detect evolving trends to inform Sanofi audit and inspection strategy and tactics • Help transform auditing practices across Sanofi’s global quality organizations, country organizations, and third parties

🎯 Requirements

• BS or BA degree in Pharmacy, Life Sciences, Engineering, or related; all degrees will be considered • Minimum 5+ years of extensive experience in GxP domains, Good Pharmacovigilance Practices, or Good Clinical Practices • Deep knowledge of global regulatory requirements and standards • Strong understanding of quality management systems (QMS) • Ability to lead cross-functional teams and initiatives • Expertise in evaluating and mitigating quality risks • Excellent written and verbal communication skills • Highly independent with creative problem-solving abilities • Strong ethical foundation with thoughtful risk-taking approach • Ability to detect evolving trends and adjust strategies accordingly • Applicants must be residents of the US or Puerto Rico

🏖️ Benefits

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