Job Title: Quality Control Support Manager

• Location: Waterford, Ireland
• Job Type: 12-Month FTC, Full-Time
• Working Arrangements: On-site

About the job

Quality Control (QC) is responsible for sample receipt, testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. The Quality Control Operations group supports Laboratory Investigations, Deviation Investigations, CAPA support, Training, and Change Controls. Quality Control Validation Support consists of the Method Validation Group and the Equipment Qualification Group. Quality Control is also responsible for assisting in site wide studies and projects.

Ready to get started?

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 people’s lives.

Main Responsibilities

• Overseeing all quality processes and digital solutions related to quality control management in compliance with the Sanofi global processes and quality control tools
• Providing QC support for all routine activities
• Leading the quality control schedule and capacity planning to support the timely release of products and the adherence of the test’s execution to the committed standard times
• Defining and maintaining the maintenance, qualification, and calibration plans to ensure valid status of the lab equipment
• Handling sample management flows from sampling to receiving and dispatching to the appropriate labs (including stability and EM sample management per plan)
• Managing reference standards and reagents for the labs
• Training management of quality control samplers or warehouse/manufacturing samplers when delegated
• Ensuring coordination of external/cross site testings, including samples flows and results reports
• Owning stability studies managed by the site in compliance with approved protocols: testing executed in a timely manner and stability result trending performed on time, including reports issuance
• Providing the appropriate quality control documentation defined in accordance with the Sanofi global processes
• Implementing and maintaining QC digital solution (core model and local) (including data management and end-user management)
• Managing and training QC support team
• Leading initiatives for continuous improvement in QC support processes in coordination with QC Excellence team
• Ensuring a quality control process supported by appropriate procedures is implemented in line with global quality and maintained locally in compliance with regulatory requirements
• Ensuring the consolidated follow-up and progress tracking of events (e.g., deviation, lab investigations), change control, CAPAs, related to QC, coordinating with respective QC areas and other involved functions, to ensure they are managed and closed as committed 
• Overseeing the Business Owners for QC processes by having QC representatives of the site in the CoPs led by global, and if requested participating in the CoEs, and ensuring local communication

About you

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Industrial Engineering, or a related discipline.
• Significant relevant experience in manufacturing quality, including demonstrated experience in a managerial or leadership role.
• Good knowledge of Equipment, systems and quality improvement methodologies.
• Strong leadership, analytical, problem-solving, and communication skills.
• Six Sigma, or equivalent quality certification is an advantage.

Why choose us?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
• Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.
• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.

 

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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

The salary range for this position is :€73 200,00 - €97 600

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.