Role at a glance
- Job function
-
Manufacturing & Skilled Trades Quality Assurance & Quality Control
- Salary
- Not yet verified Check the description for pay details; an amount or pay period has not been verified.
- Location
- Swiftwater, Pennsylvania, United States
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- 5+ years of experience in Quality Assurance roles, with a strong understanding of pharmaceutical manufacturing processes and regulatory requirements
- Education
- Bachelor's degree in science, Engineering, or a related technical field; master's degree preferred
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Role Summary
The Quality Excellence Manager in Manufacturing & Supply is based primarily on-site in Swiftwater, PA, with supportive presence on the manufacturing floor. The role focuses on promoting a culture of excellence, implementing SMS 2.0 and continuous improvement, and managing the quality excellence team.
What You'll Do
- 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, in line with SMS 2.0...
- Monitor and analyze quality performance data to identify trends and areas for improvement
- Support the investigation of complex events to ensure identification of the true root cause and relevant CAPA
- Develop and maintain quality metrics and performance indicators
- Manage the quality excellence team and ensure their proper qualification for their activities
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Bachelor's degree in science, engineering, or a related technical field, with 5+ years of quality assurance and manufacturing or operational excellence experience in a regulated industry.
Required
- Bachelor's degree in science, Engineering, or a related technical field
- 5+ years of experience in Quality Assurance roles, with a strong understanding of pharmaceutical manufacturing processes and regulatory...
- 5+ years of experience in manufacturing or Operational Excellence, within the pharmaceutical, biotechnology, medical device, or another...
- 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
Preferred
- Master's degree
Original job description
Content provided by the employer
Original job description
Content provided by the employer
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 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, 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.
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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.
Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here
US and Puerto Rico Residents Only
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 - $163.583,33All 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.
About the company
Sanofi
Large Enterprise
Sanofi is a global healthcare leader committed to promoting health and well-being through the development of innovative medicines, vaccines, and therapeutic solutions. With a diverse portfolio that spans multiple therapeutic areas, including diabetes, oncology, and immunology, Sanofi is dedicated to addressing pressing health challenges and improving patient outcomes worldwide. Headquartered in France, the company employs over 100,000 individuals across more than 100 countries, fostering a culture of collaboration and scientific excellence to drive advancements in healthcare.