Quality Compliance Specialist

Job Title: Quality Compliance Specialist

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:

Contributing to the development and maintenance of an effective compliance program

• Ensuring all operations comply with relevant regulatory requirements and other international standards

• Providing training and guidance to employees on compliance-related topics

• Maintaining compliance-related documentation, ensuring accuracy and completeness

• Identifying potential compliance risks and contributing to the development of strategies to mitigate them

• Supporting the investigation and reporting of compliance incidents

• Managing CAPA to address compliance incidents and preventing recurrence

• Contributing to continuous improvement initiatives to enhance compliance processes and systems

• Preparing and participating in internal and external audits and regulatory inspections

• 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.

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

• Participate in and/or lead formal risk assessments.Support management on compliance topics

• Review the relevance of remediation action from findings from internal and external audits related to health-related topics

Key Roles:

• Advise on improvements to compliance processes and systems

• Advise on risk mitigation strategies

• Advise on corrective actions for compliance incidents

• Advise on continuous improvement initiatives

• Coordinate quality alert and batch recall process with global team

About You

Experience:

• 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 mini

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

• Experience in ensuring compliance with local, national, and international pharmaceutical regulations and standards

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

• 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.

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 de

• 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 re