Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Location: Framingham, MA

About the Job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Monday-Friday, day shift.

About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
 

Main Responsibilities:

• 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 shopfloor

• 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

Section 3: Key involvement in Decision Making process

Key roles (D,A,I)

• 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 shopfloor (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)

About You

Requirements/Qualifications

Expected Experience

• 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

Expected Technical skills

• 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

Why Choose Us

• 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 ben