Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Location: Framingham, MA

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life‑changing treatments reach people everywhere, faster. Monday‑Friday, day shift.

• Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements
• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
• Conducting regular audits of production processes to identify and address potential quality issues
• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shop floor
• Managing and resolving quality‑related issues in a timely and effective manner
• Monitoring and analyzing quality performance metrics, implementing corrective actions as needed
• Leading root cause analysis investigations for quality incidents and implementing preventive measures
• Participating in internal and external audits and regulatory inspections providing support and documentation
• Developing and implementing risk management strategies to mitigate potential quality issues
• Fostering a culture of quality and continuous improvement across the organization

• Request corrections when GMP rules are not respected (D)
• Prioritize quality and compliance objectives (A)
• Proactively implement remediation action from findings from internal and external audits related to quality issues (D)
• Request quality improvement initiatives and strategies (D)
• Identify discrepancies and corrective/preventive actions that need to be taken (D)
• Escalate to upper management any failure in GMP execution on shop floor (I)
• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)
• Advise on how to present a topic and answer specific questions (A)
• Advise on risk management strategies and plans (A)
• Advise on initiatives to promote a quality‑focused culture (A)

• BS – Life Sciences or related discipline is preferred but a combination of education and experience will be considered.
• Minimum of 2 years of experience in quality assurance within the pharmaceutical industry
• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles

• Ability to analyze complex data and identify trends, issues, and solutions
• High level of accuracy and attention to detail in all quality assurance activities
• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
• Proficiency in identifying problems and implementing effective corrective actions
• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards

• 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 wellness benefits including high‑quality healthcare, prevention and wellness programs and at least 14 weeks’ gender‑neutral parental leave.

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, nationality, age, ancestry, marital status, gender, sexual orientation, disability, veteran or military status, domestic violence victim status, genetic information or any other characteristic protected by law.

The salary range for this position is: $78,000 - $130,000. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs.