Quality Excellence Manager

Location: Swiftwater, PA

About the role

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.

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 lives.

Responsibilities

• Promoting a culture of excellence and ensuring full implementation and sustainability of SMS 2.0
• Identifying and implementing continuous improvement initiatives to enhance product quality and operational efficiency, in line with SMS 2.0 methodology
• Monitoring and analyzing quality performance data to identify trends and areas for improvement
• Supporting the investigational process of complex events to ensure the identification of the true root cause and relevant CAPA
• Developing a culture of continuous improvement within the site
• Developing initiatives for staff and management team to foster the capacity to identify and implement quality improvements
• Developing and maintaining quality metrics and performance indicators
• Conducting regular assessments of quality processes and facilities
• Implementing in quality department global quality initiatives related to operational excellence
• Managing the quality excellence team and ensuring their proper qualification for their activities
• Actively contributing to global networking and initiatives
• Primarily on-site office-based with supportive presence on the manufacturing floor and ability to gown for Gembas

Decision-making authority

• Decide on continuous improvement strategy and roadmap
• Advise on quality improvements and initiatives
• Advise on data-driven quality improvements
• Establish quality metrics in line with global quality
• Decide on initiatives to promote a culture of continuous improvement
• Advise on the development of quality performance metrics and reporting systems

Qualifications

• Bachelor's degree in Science, Engineering, or a related technical field; master's degree preferred
• 5+ years of experience in Quality Assurance roles, with a strong understanding of pharmaceutical manufacturing processes and regulatory requirements
• 5+ years of experience in manufacturing or Operational Excellence, within the pharmaceutical, biotechnology, medical device, or another closely related regulated industry

Skills

Technical skills

• Ability to analyze complex data, identify trends, and make data-driven decisions to improve quality processes
• Proficiency in Excel and Power BI to build dashboards and visualize insights
• Leadership skills to guide cross-functional teams, manage projects, and drive quality initiatives
• In-depth understanding of regulatory requirements and GMP in the pharmaceutical industry
• Strong presentation skills, with the ability to communicate data-driven insights clearly to cross-functional teams and leadership

Soft skills

• Strong communication and interpersonal skills, with the ability to influence without direct authority
• Strong time management and prioritization in a fast-paced, cross-functional environment
• Proactive, solution-oriented mindset, with the ability to anticipate risks and define clear action plans

Benefits

• Thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs
• Opportunities to grow your talent and drive your career through promotions or lateral moves, at home or internationally
• Work with cutting-edge technology, leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime