Sanofi Group Principal Quality Engineer in Framingham, Massachusetts
Position Title: Principal Quality Engineer – Quality Systems
Location: Framingham, Massachusetts
WHO YOU ARE:
You are a flexible learner who can take on multiple aspects of Quality Systems and/or Quality Compliance.
You have the ability to work across the organization to influence Quality Culture and ensure adherence to regulations.
You have experience leading cross-functional teams to drive for results that are right the first time.
WHO WE ARE:
Our mission is to demonstrate an ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all of our products and services.
We provide leadership, guidance, and oversight of the Quality Policy, Quality Systems, and Compliance Framingham Biologics site.
We constantly strive to make Sanofi a great place to work, and a company respected for the quality of products and performance of people.
WHERE WE ARE:
Our facility is in Framingham, Massachusetts. Framingham is a suburban community located about 20 miles west of Boston in beautiful, affordable Central Massachusetts with convenient highway access and free on-campus parking and shuttle service.
Our campus complex currently incorporates thirteen buildings. We have recently completed an overhaul of one of our manufacturing complexes and it was heralded as the ISPE Factory of the Year. Several of our newer buildings have been constructed using “green” technology and resources.
Work closely with functional teams including QA, QC, Facilities, Engineering, MSAT, Manufacturing, Planning/Logistics to provide guidance and expertise on Interpretation of cGMP, regulatory requirements, directives, and guidelines from Corporate Quality management and/or from established regulatory agencies as pertaining to day-today (e.g. failure investigations, procedure clarification) and/or inspectional decision making.
Review and perform Quality Assurance approval of complex change controls, responses, investigations, and CAPAs. Apply and interpret current regulations, requirements of Sanofi standards, and local procedures, to ensure records are clearly and appropriately justified.
Facilitate, participate in and/or lead formal risk assessments.
Support continuous improvement of quality and manufacturing systems using LEAN tools and implementation of actions arising from continuous improvement events.
Perform the review and approval of technical documents and determine interrelated impacts to processes and systems.
- Bachelor's Degree and a minimum of 9 years of experience working in a regulated GMP environment to include operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing, Technical Support, Facilities, Engineering or Automation
- Master’s Degree and a minimum of 6 years of experience working in a regulated GMP environment to include operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing, Technical Support, Facilities, Engineering or Automation
Knowledge in regulatory health agency regulations (FDA, EMA, etc.)
Experience in change control
Experience in Supplier Management
Experience in project management
Demonstrated leadership in conducting cross-functional team meetings and/or projects
Experience with LEAN manufacturing (problem-solving, LEAN tools) or comparable continuous improvement systems
Experience with KPI generation and presentation
Experience participating in international external regulatory health agency inspections
Knowledge of regulatory agency enforcement trends
Experience implementing digital technologies
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.