Job Description

SUMMARY:

Work with suppliers and act as the liaison between the Procurement Department and QA to ensure suppliers/vendors continue to deliver quality products and services to the facility.

This responsibility will be realized through participation in the Supplier Management Team, performing supplier/vendor audits, maintaining the supplier corrective action program, and interaction with the individual supplier/vendor as appropriate. 

Plan, perform, and oversee the auditing process that includes timely completion of tasks in Phenix.

Monday - Friday First Shift with occasional overtime.

Travel and onsite base position. Auditing of suppliers/vendors may involve an overnight stay and abroad travel as required (Approximately 20% travel).

JOB RESPONSIBILITIES

Document supplier audit results 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 Supplier/Vendor 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 assure compliance. Drive 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.

Managed professional relationship with suppliers/vendors to ensure their adherence to quality standards and facilitate environment of continual improvement.

The Incumbent will ideally have some Project Management experience and will be capable of implementing projects, initiatives, and improvements either as an individual contributor or as part of a team.

Performance of trending and metric generation will be required as part of this role to ensure compliance and provide confidence that the relevant quality systems are operating. in control.

This position works with Manufacturing Operations, QA Management, Procurement and Suppliers, and Service Providers to provide advice and support in the resolution of compliance-related concerns and initiatives and apply their own professional knowledge to proactively identify areas of risk to compliance GMP’s.

Will be responsible for authoring, reviewing, and approving GMP documentation and may be responsible for developing and delivering training related to supplier management topics.

Will be assisting in authoring, revising, and maintaining QTA’s between vendors and service providers, and liaison with respective parties such as Procurement and Legal.

HSE

It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility

The individual must support all Sanofi and site HSE policies as well as ensure that work performed is compliant with local HSE regulations

Individuals must complete all required HSE trainings. Everyone is required to report all accidents timely closure of HSE actions owned by their departments

EDUCATION / EXPERIENCE:

Basic Qualification:

Bachelor’s degree in Science disciplines.

Minimum four years of pharmaceutical industry experience.

Minimum four years of auditing experience.

In-depth understanding of auditing and control practices.

Preferred Qualifications

Extensive Supplier Management experience,

Proven ability to conduct and manage audits.

Strong understanding in FDA CFR Parts 11, 210, 211, and 820, ISO 13485, 9001 and/or other applicable regulations.

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

Handling Audits, ASL, and QTAs, usage of Athena and Phenix.

Very good communicator, writing and organizational skills.

Ability to travel and work remotely across functions.

Ability to multi-task.

Adaptable to change.

Ability to work in a team as well and individually.

Ability to draw on past experiences to influence future outcomes.

Ability to research information for problem resolution to projects.

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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