Quality Engineer

Job Title: Quality Engineer

Location: Northborough, MA

About the Job

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.

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?

Main Responsibilities:

• Developing, implementing, and maintaining effective Quality Management Systems (QMS)

• Ensuring that the site complies with all laws, regulations, and standards applicable in the pharmaceutical industry

• Ensuring the company is always prepared for inspections by regulatory bodies for topics related to dossier compliance

• Provide training and guidance to employees on compliance topics from global Sanofi standards applicable for the site

• Participating in regulatory inspections and audits (internal and external bodies)

• Identifying compliance risks and contributing to the development of strategies for mitigation

• Ensuring any compliance incidents are properly reported and investigated with the implementation of appropriate corrective actions

• Overseeing the maintenance and management of compliance-related documentation

• Identifying and leading continuous improvement initiatives to enhance compliance

• Perform the Quality Assurance review and approval of change controls, deviations, 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 Quality System requirements within agreed timelines.

• Work closely with manufacturing, quality and support groups to develop effective CAPA.

• 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.

Key Roles:

• Advise on improvements to compliance processes and systems

• Decide on corrective actions for compliance incidents

• 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 SMS tools and implementation of actions arising from Lean and other continuous improvement events.

About You

Experience:

• Bachelor's degree in Science or Engineering and a minimum of 9 years experience working in a regulated, cGXP environment or Master's degree and a minimum of 6 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 experience with project management.

• Demonstrated proficiency in critical thinking and technical writing.

• Extensive experience in ensuring compliance with local, national, and international pharmaceutical regulations and standards.

• Proven experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up

Technical Skills:

• In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH)

• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions

• Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders

• Proficiency in managing multiple compliance projects simultaneously, ensuring timely completion and adherence to standards

• Keen attention to detail to ensure accuracy in compliance documentation, audits, and reports

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

• Experience with root cause analysis tools and gap identification

Why Choose Us?

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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