Quality Excellence Manager

Regulatory Toolkit; Pennsylvania; Presencial; USD 113.000 - 164.000; Jornada completa

Descripción de la vacante

Sanofi Swiftwater, PA is seeking a Quality Excellence Manager to lead the site quality improvement agenda within Manufacturing & Supply. You will drive SMS 2.0 adoption, build dashboards in Excel/Power BI, and mentor a quality excellence team on an on-site basis.

The role requires a bachelor’s in science/engineering, 5+ years in QA and manufacturing/regulatory exposure, and strong data analysis, communication, and leadership skills to advance global quality initiatives.

Formación

• Bachelor's degree in science,Engineering, or related field; master's preferred.
• 5+ years in Quality Assurance roles with pharmaceutical manufacturing/regulatory exposure.
• 5+ years in manufacturing/Operational Excellence in regulated industry.

Responsabilidades

• Promote a culture of excellence and ensure SMS 2.0 implementation.
• Identify and implement continuous improvement initiatives for quality and efficiency.
• Monitor quality performance data to identify trends and drive improvements.
• Support investigational processes to determine root causes and CAPA.
• Develop and maintain quality metrics and KPI dashboards.
• Lead the quality excellence team and ensure proper qualifications for activities.

Conocimientos

Data analysis

Leadership

Cross-functional collaboration

Communication

Educación

Bachelor's degree in science/engineering

Master's degree preferred

Herramientas

Excel

Power BI

Descripción del empleo

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.

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.

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.

US and Puerto Rico Residents Only

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.