Quality Excellence Manager

Sanofi; Swiftwater (Monroe County); On-site; USD 113,000 - 164,000; Full time

Benefits offered by this job

Health benefits

Career growth opportunities

On-site work

Job summary

Sanofi in Swiftwater, PA is seeking a Quality Excellence Manager to lead the site’s quality improvement program and sustain SMS 2.0 practices. You will coach the quality excellence team, align metrics with global quality goals, and drive data‑driven decisions on product quality and process performance on the manufacturing floor.

You’ll collaborate with cross‑functional partners, implement CAPA programs, and ensure regulatory compliance across GMP frameworks.

Qualifications

• Bachelor's degree in science, engineering, or a related technical field.
• Master's degree preferred for advanced roles.
• 5+ years in Quality Assurance roles with strong GMP/pharma manufacturing exposure.

Responsibilities

• Promote a culture of excellence and ensure full implementation and sustainability of SMS 2.0.
• Identify and implement continuous improvement initiatives to enhance product quality and operational efficiency (SMS 2.0).
• Monitor and analyze quality performance data to identify trends and improvement areas.
• Support the investigational process of complex events to determine true root causes and relevant CAPAs.
• Develop a culture of continuous improvement within the site and lead quality performance metrics.

Skills

Quality Assurance

Operational Excellence

Data analysis

Leadership

Education

Bachelor's degree in science or engineering

Master's degree preferred

Tools

Excel

Power BI

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.

Equal Opportunity Statement 1

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and AffiAll 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.

Equal Opportunity Statement 2

Sanofi US endeavours to make our career center accessible to any and all users. Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

North America Applicants Only

The salary range for this position is: $113.250,00 - $163.583,33 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.

#GD‑SP #LI‑SP #VHD Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Discover more about us

Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug‑discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.