Quality Excellence Manager
Job in
Pittsburgh, Allegheny County, Pennsylvania, 15201, USA
Listing for:
Regulatory Toolkit
Full Time
position
Listed on 2026-11-07
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Job Title
:
Quality Excellence Manager
Location: Swiftwater, PA
About the JobJoin a global network that powers how Sanofi delivers — seamlessly, purposefully, and 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.
- 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)
- 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.
- 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
- 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
- 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…
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