Global Quality Auditor

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Ensure adherence to Sanofi Quality and Compliance Standards as well as relevant regulatory requirements.

• Perform independent audits and address any findings that arise.

• Serve as the lead auditor or co-auditor in accordance with Sanofi's established processes.

• Assist in the qualification process for new auditors.

• Execute transversal assessments across various functions.

• Prepare, coach, and support entities for regulatory inspections, including those that are unannounced or on short notice.

• Engage in external associations to stay informed about emerging trends.

• Assess entity risks using targeted risk-based agendas and provide mitigation recommendations.

• Raise awareness of critical issues and risks as they arise.

• Approve and manage Corrective and Preventive Actions (CAPAs).

• Participate in Quality Governance Committees such as IRISC.

• Collaborate on audits and activities with Sanofi's Quality Audit, Inspection, Intelligence & Advocacy teams.

• Contribute to the departmental Quality Management System (QMS), including training programs, standard audit agendas, and controlled documents.

• Lead cross-functional teams for various initiatives or projects as necessary.

• Identify evolving trends and assist in refining Sanofi's audit and inspection strategies and methodologies.

• Revolutionize auditing practices throughout Sanofi.

• Oversee Manufacturing & Supply, Research & Development, Country Offices, Digital, Global Quality organizations, and external parties.

⛳️ Requirements

• Bachelor's degree in life sciences, pharmacy, engineering, or a related field.

• Over 5 years of experience in quality auditing, preferably in the pharmaceutical or biopharma sector.

• Proven experience in cGMP environments, regulatory inspection support, and risk-based audit methodologies.

• Comprehensive understanding of international regulatory requirements and major health authorities, including US FDA, EMA, ANSM, NMPA, PMDA, and ANVISA.

• Expertise in audit methodologies, CAPA management, and risk assessment frameworks.

• Highly independent and self-motivated, with a strong focus on compliance.

• Ability to think innovatively while taking well-considered risks.

• Proven leadership skills and the ability to collaborate across functions.

• Willingness and capacity to travel domestically and internationally, approximately 50% of the time.

• Proficient in both written and spoken English.

• French language skills preferred for roles based in Europe.

• Exceptional written and verbal communication abilities.

• Strong analytical and problem-solving skills.

• Ability to recognize evolving trends and utilize data and metrics to evaluate the effectiveness of quality systems in relation to governing requirements.

🏝️ Benefits

• Opportunities for advancement or lateral career transitions, both domestically and internationally.

• A comprehensive rewards package.

• Access to high-quality healthcare.

• Preventive and wellness programs.

• At least 14 weeks of gender-neutral parental leave.

• Opportunities to work with cutting-edge technology, digital tools, data, and AI-driven innovations.