Senior Quality Engineer

Job Title: Senior Quality Engineer

About the Job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

The Quality Assurance (QA) Operations department is responsible for quality oversight of operations at Sanofi Framingham Biologics facilities. QA’s main responsibility is to ensure adherence to CGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities.

Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi’s products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company’s business and global markets

Main Responsibilities:

• Demonstrate strong leadership qualities and embody Sanofi's core leadership principals. 

• Develop integrated work plans and represent the Quality Assurance CAPA-Deviation- Investigation (CDI) team on integrated work teams. 

• Participate in policy discussions and represent the Quality Assurance CDI team on issues impacting the direction of quality in the organization. 

• Perform the Quality Assurance review and approval of complex change controls, deviations, Environmental Monitoring/Critical Utility investigations, laboratory investigations, and CAPAs to ensure that they meet the requirements of Sanofi standards and procedures, and are clearly and appropriately justified. 

• Perform product complaint investigations. 

• Work closely with manufacturing, quality and support groups to resolve all deviations within agreed timelines. 

• Facilitate department regulatory related CAPAs and audit responses. 

• Work closely with manufacturing, quality and support groups to develop effective CAPA to reduce deviation reoccurrence and for continuous improvement. 

• Participate in department regulatory related CAPAs and audit responses. 

• Generate and present assigned metrics at the required frequency which drive accountability and delivery of targets. 

• Participate in and/or lead formal risk assessments.

• Review and provide guidance for proposed and existing changes through the formal change control process as it applies to validated processes, equipment and test methods.

• Apply and interpret Sanofi corporate standards and local procedures governing the change control process to proposed changes, consulting with QA management as appropriate. 

• Work with project teams to determine the change control approach for complex projects. 

• Ensure that changes affecting more than one site are evaluated and approved through the multi-site change control process.

• Perform quality SME assessments. Work closely with the Operational Excellence to support continuous improvement of quality and manufacturing systems using Sanofi Manufacturing System tools and implementation of actions arising from Lean and other continuous improvement events. 

• Perform the review and approval of technical documents and determine interrelated impacts to process and systems. Ensure completeness and correctness of items such as engineering studies, Technical Reports, Engineering drawings and MBRs/SOPs. 

• 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.

This includes:

• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures. 

• Being honest and treating people with respect and courtesy. 

• Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products. 

• Acting as role models for our fellow employees by acting responsibly, fairly, and  honestly in our dealings and exercising sound judgment in performing our jobs.

About You

Basic Qualifications

• Bachelor's degree in Science or Engineering and a minimum of 6 years’ experience working in a regulated, cGXP environment or Master's degree and a minimum of 3 years' experience working in a regulated, cGXP environment. 

• Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation. 

• Demonstrated knowledge of cGXP regulations and guidance. 

• Demonstrated experience with change control, CAPA and deviation quality systems. 

• Demonstrated proficiency in critical thinking and technical writing.

Preferred Qualifications

• Experience with SMS, LEAN Manufacturing (problem solving/use of Lean tools) or comparable continuous improvement systems. 

• Experience with root cause analysis tools and gap identification

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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