Global Quality Auditor

Regulatory Jobs; United States; Remoto; USD 134.000 - 193.000; Tempo pieno

Descrizione del lavoro

Sanofi Inc. in the United States is seeking a Global Quality Auditor to lead GxP audits across global quality.

The role emphasizes independence, risk-based auditing, and CAPA management, with collaboration across cross-functional teams to elevate audit effectiveness and compliance. The position requires five-plus years in GxP domains, strong knowledge of GCP/GVP, and a deep understanding of global regulatory standards; remote work is available within the US and international collaborations are

Competenze

• BS/BA in Pharmacy, life sciences, engineering, or related field.
• Minimum 5+ years of experience in GxP domains (GCP or GVP).
• Knowledge of global regulatory requirements and standards.

Mansioni

• Covers all GXP audit in GCP and GVP areas.
• Acts as lead auditor or co-auditor per Sanofi processes.
• Conducts transversal assessments and reviews audit reports.
• Evaluates entity risks and develops risk-based agendas.
• Escalates critical issues and manages CAPAs.
• Participates in audits with Sanofi Quality Audit, Inspection, Intelligence & Advocacy.
• Contributes to departmental QMS, training curricula, and standard agendas.

Conoscenze

Leadership

Risk Assessment

Communication

Independence

Compliance Mindset

Adaptability

Formazione

Bachelor's degree in Pharmacy or life sciences

Descrizione del lavoro

Job Title: Global Quality Auditor

• Location:Remote within US

About the Job

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 people’s lives.

Main Responsibilities

• Covers all GXP audit in areas of current, Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP).
• Acts as a lead auditor or co-auditor, in accordance with Sanofi processes.
• Conducts transversal assessments.
• Contributes to team scheduling and reviews/approves audit reports for team members.
• Evaluates entity risks developing targeted risk-based agendas and/or advise on mitigations.
• Escalates critical issues and risks.
• Approves / manages CAPAs.
• Performs due diligence assessments, as/when needed.
• Participates in audits and activities with other teams in Sanofi Quality Audit, Inspection, Intelligence & Advocacy.
• May contribute to the creation of departmental QMS such as Training Curriculum, standard audit agendas, and controlled documents.
• 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 key role in transforming the practice of auditing in Sanofi.
• Scope: Global Quality organizations in Sanofi, country organization, and third parties outside of Sanofi (e.g. Strategic Vendors, etc.)

About You

Basic Qualifications:

• BS or BA degree in Pharmacy, Life Sciences, Engineering, or related, but will consider all degrees.
• Minimum 5+ years of extensive experience in GxP domains, Good Pharmacovigilance Practices, or Good Clinical Practices.

Preferred Qualifications:

• Deep knowledge of global regulatory requirements and standards.
• Strong understanding of quality management systems (QMS).

• Leadership Skills: Ability to lead cross-functional teams and initiatives
• Risk Assessment: Expertise in evaluating and mitigating quality risks
• Communication: Excellent written and verbal communication skills
• Independence: Highly independent with creative problem-solving abilities
• Compliance Mindset: Strong ethical foundation with thoughtful risk-taking approachAdaptability: Ability to detect evolving trends and adjust strategies accordingly

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 it’s 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 and Affi­ mcative Action employers committed to a culturally diverse 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.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

US and Puerto Rico Residents Only

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.

North America Applicants Only

The salary range for this position is:

$133,500.00 - $192,833.33

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.