Job Title: Senior Quality Engineer

Location: Ridgefield, NJ

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Senior Quality Engineer is part of the Quality Assurance Department at Ridgefield, NJ. This role is responsible for supporting the Change Control and Risk Management Quality Systems.

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?

• Perform Quality assessments on all new change controls and assist in the determination of the required actions and deliverables for implementation and closure, based on the criticality and product impact of the proposed change.
• Act as a risk facilitator in the completion of formal and less formal risk assessments.
• Represent Change Control and Risk Management programs during internal and external audits.
• Participate in Change Control Community of Practice and serve as Site Contact for Multi-site Change Control Assessments
• Collaborate with LIMS, Documentation Management, and Product Release departments for change control holds and coordinate implementation timing.
• Provide CCR Users with direction and guidance for Change Controls and on the use of the Phenix CCR Module
• Mentors site personnel in risk tool vetting process, risk strategy development, and in all other risk inquiries.
• Follow up with change control owners and task owners to ensure that required actions are completed in a timely and compliant manner.
• Assists in the oversight of the site's Change Control and Risk Management Programs by monitoring the status of open items and compiling/reviewing program metrics.
• Perform annual review of changes to assess cumulative effect of changes on process performance, product quality or on the overall validation status of the affected process, facility, or system.
• Complete living risk reviews and determine requirement to update risk assessment documents.
• Support continuous improvement of the Change Control and Risk Management systems to simplify and streamline ways of working by trending metrics for the programs.
• Perform Product Quality Reviews
• HSE
• 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.

• A minimum bachelor's degree is required (preferably in Life Sciences or Engineering) with 5 years of Quality experience which must include Change Control or Quality Risk Manaqement
• 7 years of Quality Systems and/or Quality Compliance experience preferred

• 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.