Quality Assurance Auditor
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Do you have what it takes for a successful career with Sanofi?
- Team player
Culture: Play to Win
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."
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.
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
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.
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.