Global Quality Auditor

BioSpace; Kansas; Híbrido; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Sanofi is seeking a Global Quality Auditor to ensure GMP/quality regulatory compliance across global sites, affiliates, and third parties. The role emphasizes auditing, CAPA management, and regulatory inspections to uphold Sanofi's standards.

The candidate should have strong English proficiency, a background in life sciences or engineering, and 5+ years in quality auditing within pharma/biopharma, with willingness to travel internationally.

Formación

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• Strong knowledge of cGMP and regulatory requirements across major health authorities.
• Experience with risk-based audit methodologies and CAPA processes.

Responsabilidades

• Conduct audits as lead or co-auditor per Sanofi processes.
• Coach and qualify new auditors; support regulatory inspections.
• Identify entity risks and develop risk-based agendas; advise on mitigations.
• Escalate critical issues, approve CAPAs, and participate in governance committees.

Conocimientos

Auditing

Regulatory inspections

CAPA management

Risk assessment

Educación

Bachelor's degree in life sciences/related field

MSc/PhD preferred

Descripción del empleo

Job Title: Global Quality Auditor Location: Morristown, NJ ,Remote About the Job Ensures that Sanofi Quality and Compliance Standards, and applicable regulatory authorities requirements are met and that all Sanofi sites, Operational Units, affiliates, and third parties achieve, maintain and improve the adequate level of compliance, through independent auditing and follow-up. Foster best-in-class performance by leveraging data, technology and diverse talents to support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration, Innovation, Expertise. This critical role: Covers all commercial activities. Covers Current Good Manufacturing Practice (cGMP), Good Distribution Practice (GDP). Supports Sanofis Diverse product portfolio across all GBUs; Specialty Care, Vaccines, General Medicines. Internal and External Auditing (e.g., CMOs, Opella CHC, etc.) and Regulatory Inspections. Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products Administration (China), PMDA (Japan), ANVISA (Brazil). Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi: Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives. Main Responsibilities Acts as a lead auditor or co-auditor, in accordance with Sanofi processes. Supports qualification of new auditors. Conducts transversal assessments. Prepares, coaches, and supports entities for Regulatory Inspections through varying methods such as unannounced or short-notice visits. Participates in External Associations to stay current with emerging trends. Evaluates entity risks by developing targeted risk-based agendas and/or advise on mitigations. Escalates critical issues and risks. Approves/manages CAPAs. Participates in Quality Governance Committees (e.g., IRISC) as/when needed. Participates in audits and activities with other teams in Sanofi Quality Audit, Inspection, Intelligence & Advocacy as needed. May contribute to the creation of departmental QMS such as Training Curriculum, standard audit agendas, and controlled documents. Management: No direct reports. May lead cross-functional teams for initiatives or projects. Latitude of action: Highly independent, creative with thoughtful risk taking and compliance mindset. Role impact: Able to detect evolving trends which will result in adjustment of Sanofi audit and inspection strategy and tactics. Plays a role in transforming the practice of auditing in Sanofi. Scope: Manufacturing & Supply, Research & Development, Country Offices, Digital, Global Quality organizations in Sanofi, and third parties outside of Sanofi (e.g., Alliance Partners, CMOs, Strategic Vendors, etc.). About You Basic Qualifications Bachelors degree in relevant degree in life sciences, pharmacy, engineering, or any field; advanced degree (MSc, PharmD, PhD) preferred. 5+ years' experience in quality auditing preferably within the pharmaceutical or biopharma industry. Preferred Qualifications: 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 and the 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 (on average approximately 50%). Fluent written and spoken English, for Europe-based role French-speaking preferred. Excellent written and verbal communication skills, with the ability to convey complex compliance matters clearly to diverse audiences including site teams and senior leadership. Strong analytical and problem-solving capabilities to detect evolving trends and leverage data and metrics to assess quality system effectiveness against governing requirements. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeks gender-neutral parental leave. Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply. Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale Transform lives worldwide by delivering life-changing treatments anywhere, anytime. Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #VHD All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.