Quality Excellence Manager

Sanofi; Pocono Township (PA); Presencial; USD 113.000 - 164.000; Tempo integral

Resumo da vaga

Sanofi in Swiftwater, PA is seeking a Quality Excellence Manager to lead the site’s quality improvement program, with a strong focus on sustaining SMS 2.0 and driving data-driven quality initiatives. This on-site role will manage the quality excellence team and collaborate with cross-functional partners on quality improvements.

You will engage in global quality initiatives, develop quality metrics, and support CAPA investigations.

Qualificações

• Bachelor’s degree in science, engineering, or related technical field; master’s degree preferred
• 5+ years of experience in Quality Assurance roles with pharmaceutical manufacturing/regulatory exposure
• 5+ years of experience in manufacturing or Operational Excellence in pharma/biotech/regulated industry

Responsabilidades

• 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 per SMS 2.0
• Monitoring and analyzing quality performance data to identify trends and areas for improvement
• Supporting the investigational process of complex events to identify root causes and relevant CAPA
• Developing a culture of continuous improvement within the site
• Developing initiatives for staff and management to foster capability 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 proper qualification for activities
• Actively contributing to global networking and initiatives
• Primarily on-site office-based with supportive presence on the manufacturing floor and gowning for GMP events

Conhecimentos

Data analysis

Leadership

Quality improvement

Cross-functional collaboration

Problem solving

Communication

Formação

Bachelor's degree in science/engineering

Master's degree preferred

Ferramentas

Excel

Power BI

Descrição da vaga

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 Aff... (the full long paragraph continues)

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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.