Quality Excellence Manager

Sanofi•Swiftwater, PA

21h•Onsite

About The Position

The Quality Excellence Manager promotes a culture of excellence and ensures the implementation and sustainability of Sanofi Manufacturing System (SMS) 2.0. The role identifies and implements continuous improvement initiatives to enhance product quality and operational efficiency, monitors quality performance, supports complex investigations, and develops quality metrics and performance indicators. The manager also conducts assessments of quality processes and facilities, implements global quality operational excellence initiatives, and manages and qualifies the quality excellence team. The position contributes to global networking and initiatives. The role is primarily office-based onsite, with a supportive presence on the manufacturing floor and the ability to gown for Gembas. It makes decisions on the continuous improvement strategy and roadmap, quality metrics aligned with global quality, and initiatives that promote continuous improvement, and advises on quality improvements, data-driven improvements, and performance metric and reporting system development.

Requirements

Bachelor's degree in science, engineering, or a related technical field.
At least 5 years of experience in Quality Assurance roles.
Strong understanding of pharmaceutical manufacturing processes and regulatory requirements.
At least 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 pharmaceutical industry regulatory requirements and GMP.
Strong presentation skills and ability to communicate data-driven insights clearly to cross-functional teams and leadership.
Strong communication and interpersonal skills, including the ability to influence without direct authority.
Strong time management and prioritization skills in a fast-paced, cross-functional environment.
Proactive, solution-oriented mindset and ability to anticipate risks and define clear action plans.

Nice To Haves

Master's degree.

Responsibilities

Promote a culture of excellence and ensure full implementation and sustainability of SMS 2.0.
Identify and implement continuous improvement initiatives that enhance product quality and operational efficiency in line with SMS 2.0 methodology.
Monitor and analyze quality performance data to identify trends and areas for improvement.
Support investigations of complex events to identify the true root cause and relevant corrective and preventive actions (CAPA).
Develop a culture of continuous improvement within the site.
Develop initiatives for staff and management to build the capacity to identify and implement quality improvements.
Develop and maintain quality metrics and performance indicators.
Conduct regular assessments of quality processes and facilities.
Implement global quality initiatives related to operational excellence within the quality department.
Manage the quality excellence team and ensure team members are properly qualified for their activities.
Contribute to global networking and initiatives.
Decide on the continuous improvement strategy and roadmap.
Establish quality metrics in line with global quality requirements.
Decide on initiatives to promote a culture of continuous improvement.
Advise on quality improvements and initiatives, data-driven quality improvements, and development of quality performance metrics and reporting systems.