Sr. Quality Supplier Auditor/Sr. Supplier Quality Engineer

Job Purpose:

• Work with suppliers and acts as the liaison between the site and Global Quality team to ensure suppliers/vendors continue to deliver quality products and services to the company.

• This responsibility will be realized through the participation in the Supplier Quality Management (SQM) team, performing supplier/vendor audits, maintaining the supplier corrective action program, managing the site’s Quality Agreement (QAg) portfolio, and interaction with the individual supplier/vendor as appropriate.

• Plan, perform and oversee the auditing process that includes timely completion of audits and quality agreements in the Quality System (currently using Phenix).

• Monday-Friday, First Shift with occasional overtime. Hybrid work schedule (3 days on site).

• Auditing of suppliers/vendors may involve travel and overnight stays both domestically and internationally (up to 25% travel may be required).

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.

• Capable of Project Management exercises to implement SQM projects, initiatives, and improvements either as an individual contributor or as part of a team.

• Ability to work with cross functional teams including Manufacturing Operations, QA Management, Supply Chain, and Service Providers to provide advice and support in the resolution of compliance related concerns and initiatives and apply their own professional knowledge and experience to proactively identify areas of risk to compliance GMPs.

• Responsible for authoring, reviewing, and approving GMP documentation and may be responsible for developing and delivering training for related SQM topics.

• Will author, revise, and maintain the site’s Quality Agreements (QAg) portfolio between all critical suppliers/service providers and other Sanofi sites, and liaison with respective parties such as Procurement and Legal.

Requirements

Basic Qualifications:

• MUST have external supplier audit experience

• BA in Science disciplines

• Minimum four (4) years of pharmaceutical industry experience

• Minimum four (4) years of auditing experience

• In-depth understanding of auditing and control practices

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

Preferred Qualifications:

• Extensive SQM experience

• 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), QAg, usage in Athena and Phenix

• Very good communicator, writing, time management, and organizational skills

• Ability to travel and work remotely across functions

• Ability to work autonomously

• Ability to multi-task

• Adaptable to change

• Ability to work in a team as well as individually

• Ability to draw on past experiences to influence future outcomes

• Ability to research information for problem resolutions for projects and position roadblocks

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.