Quality Excellence Manager

Sanofi Group; Pennsylvania; On-site; USD 120,000 - 160,000; Full time

Job summary

Sanofi is seeking a Quality Excellence Manager in Swiftwater, PA to lead the Quality Excellence team and drive GMP-compliant initiatives across manufacturing and supply. The role emphasizes data-driven decision making, cross-functional collaboration, and global quality initiatives on site.

You will promote a culture of continuous improvement, develop metrics, and align local efforts with SMS 2.0 and regulatory requirements to ensure product quality and operational excellence.

Qualifications

• Ability to analyze complex data and identify trends to drive quality improvements.
• Proficiency in Excel and Power BI for dashboards and insights.
• Leadership skills to guide cross-functional teams and drive initiatives.

Responsibilities

• Promote a culture of excellence and ensure full implementation of SMS 2.0.
• Identify and implement continuous improvement initiatives to enhance product quality and operational efficiency.
• Monitor quality performance data to identify trends and areas for improvement.
• Support the investigational process of complex events to identify root causes and relevant CAPA.
• Develop a culture of continuous improvement within the site and foster staff development.
• Develop and maintain quality metrics and performance indicators.

Skills

Data analysis

Excel

Power BI

Leadership

GMP knowledge

Education

Bachelor's degree in science/engineering

Master's degree preferred

Job description

Job Title: Quality Excellence Manager

Location: Swiftwater, PA

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.

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 lives.

Main 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.

Key Involvement In Decision Making Process

Key Roles (D,A,I)

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

About You

Basic 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.

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

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.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff… 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, 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.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.