Sanofi Group Senior Quality Engineer in Northborough, Massachusetts
Quality Control Raw Materials is responsible for the activities at Sanofi’s Northborough Operations Center (NBO) by the inspection, testing, and sampling, of in-coming raw materials used in the manufacturing processes throughout the Sanofi organization.
Job Overview with Key Responsibilities
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
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
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.
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
Special Working Conditions
- Ability to lift 10lbs
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.