Senior Quality Engineer

The Quality Control Framingham Hub organization support the Quality Control Biologics network globally in the area stability and statistics support as well as QC Technical Services support.

In addition, the Analytical Hub Quality Control department provides compliant and timely testing support for various products, facility environmental and clean utility monitoring.

The QC Compliance organization supports the local Hub organization in all matters related to QC Compliance.

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

Position Summary

The Quality Control Senior Quality Engineer uses expert knowledge of compliance and GMP laboratory practices to manage investigations and improvement initiatives within Quality Control

Core Responsibilities include

• Investigating and writing deviations, laboratory investigations, CAPAs, Tasks, Effectiveness reviews, and audit observation responses.

• Define and implement CAPAs, tasks, and effectiveness reviews with the assistance of QC Management.

• Manage / own CCRs and liaise with functional QC units for work execution.

• Conduct self-inspection / audit walkthroughs.

• Support internal / external audits and participate in and / or lead the completion of responses to internal / external audit related observations / CAPA.

• Conduct gap assessments against external and / or other Sanofi sites audit observations and assist with plan development to drive remedial actions.

• Maintain a high level of personal compliance to the required company standards and industry best practices.

• Provide expertise during procedure / SOP revision process and function as DCR approver for department related SOPs, where required.

• Partner with QC operations and manufacturing, where applicable, to support a culture of continuous compliance / improvement.

• Assist in generating metrics at the required frequency to drive accountability and delivery of targets.

Basic Qualifications

• Bachelor's Degree in science or technical field

• 6 years' of experience in biopharmaceuticals or related industry working in a regulated,

• GMP environment or Master's degree and a minimum of 3 years' experience working in a regulated, GMP environment.

• Demonstrated knowledge of GMP regulations and guidance.

• Demonstrated experience with deviation and laboratory investigation quality systems.

Preferred Qualifications

• Working knowledge of applicable cGMP regulations.

• Proven track record of managing complex laboratory investigations / deviations.

• Experience in project management.

• Effective time management and organizational skills.

• Strong attention to detail and cross functional teams experience.

• Strong leadership skills, ability to drive accountability, compliance and efficiency throughout the department.

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

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.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

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.