Manager, Supplier Quality
Ridgefield, New Jersey
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The Supplier Quality Manager works within the Quality Assurance department at the Sanofi Ridgefield, NJ site and is responsible for overseeing the site Supplier Quality Management program.
This individual serves as the site QA contact for suppliers and internal customers.
Provides quality oversight of cGMP supplier management program and manages staff activities.
Ensures that the Supplier Management program at the site is compliant with Sanofi requirements as well as current regulatory requirements and industry practice.
Provides guidance to Manufacturing, Facilities, Engineering, Quality, and other support departments regarding the proposed use of new materials and services and how they are to be qualified and controlled under supplier lifecycle and management processes.
Reviews and approves Supplier Audit Reports and Quality Agreements.
Assures third party audits are completed on time per planned schedule.
Assures Quality Agreement are completed on time per planned schedule.
Oversees Approved Supplier List, Supplier Investigations, Corrective Action Requests, and Annual Quality Review of Suppliers.
Assesses Change Controls and Supplier Change Notifications for impact and identifies required actions needed.
Proposes and implements modifications to the supplier management program to improve compliance, efficiency, and customer satisfaction.
Represents QA Supplier Management program as subject matter expert during internal and external audits.
Participates in cross-functional teams to support introduction of new materials and service providers. Participates in material specification development and reviews and approves material specifications.
Maintains key performance indicators (KPls) for suppliers within area of responsibility, monitors performance, promptly addresses undesirable trends and escalates compliance risks as needed
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 and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.
Bachelor's degree with at least 5- 8 years of cGMP experience in industry or regulated environment OR Master's degree with at least 4 years of cGMP experience in industry or regulated environment
3 years of experience in Quality Assurance
Bachelor's degree in Science or Engineering.
Experience working with external partners (e.g. contract laboratories and suppliers).
Understanding and ability to apply pharmaceutical/medical device cGMP regulations and
guidance using a risk-based approach.
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.