Success Profile

Courageous
Results-driven
Proactive
Problem-Solver
Leadership
Team player

Job Responsibilities

• Document supplier audit in written audit reports that are distributed and reviewed by appropriate management.

• Must be able to undergo and successfully complete the Sanofi Lead Auditor Certification process.

• Assures that the Quality System audit function complies with GMP, ISO, and all applicable regulatory requirements.

• Review and evaluate audit responses against current standards, regulations, and guidelines to ensure compliance.

• Drive on time closure of corrective and preventative actions to ensure implementation, compliance, and continuing efficacy.

• Assist in maintaining the Supplier Qualification Program for existing and new suppliers/vendors, including maintaining and revising quality agreements as required.

• Manage professional relationships with suppliers to ensure their adherence to quality standards and facilitate environment of continual improvement.

Basic Qualifications

• BA in Science disciplines

• Minimum of two (2) years of pharmaceutical industry experience

• Minimum of two (2) years of auditing experience

• In-depth understanding of auditing and control practices

• Must be able to speak clearly and write reports in English

• Must have external supplier audit experience

• Auditor must be able to travel 50% within US and Canada

Preferred Qualifications

• Auditor Qualifications ASQ-CQA

• Proven ability to conduct and manage audits

• Strong understanding in FDA CFR Parts 11, 210, 211 and 820, ISO 134845, 9001 and/or other applicable regulations

• Strong knowledge of quality and compliance in regulated GxP/QMS environment

• Handling Audits, Approved Supplier List (ASL), Quality Agreements (QAg)

• Very good communication, report writing, time management, and organizational skills

• Ability to travel and hybrid work across functions

• Ability to work in a team as well as individually

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative 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.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.