Quality Specialist

Quality Specialist

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

Key Involvement in Decision Making Process:

• Support management on compliance topics (A)
• Review the relevance of remediation action from findings from internal and external audits related to health-related topics (A)
• Advise on improvements to compliance processes and systems (A)
• Advise on risk mitigation strategies (A)
• Advise on corrective actions for compliance incidents (A)
• Advise on continuous improvement initiatives (A)
• Coordinate quality alert and batch recall process with global team (A)

About You

Basic Qualifications

• Bachelors with 2+ years experience in quality assurance
• Or HS Diploma 10+ years' experience in quality assurance
• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles

Preferred Qualifications

• Knowledge of local and international pharmaceutical regulations (e.g., FDA, EMA, ICH)
• Experience with audits and regulatory inspections, including prep and follow-up
• Strong problem-solving skills for compliance issues and root cause analysis
• Clear communication of compliance requirements to stakeholders
• Ability to manage multiple compliance projects and meet deadlines
• High attention to detail in documentation, audits, and reports

Language

• Local language and English

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 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; 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.