Quality Control Support Manager

Sanofi; Waterford; On-site; EUR 65,000 - 90,000; Full time

Job summary

Sanofi Group in Waterford, Ireland is seeking a Quality Control Support Manager to lead QC activities for site operations. You will oversee quality processes, manage a team, and ensure compliance with CGMP standards while coordinating with cross-functional functions.

The role emphasizes maintenance of equipment qualification plans, sample management, and data handling for quality control initiatives. Strong leadership and Six Sigma familiarity are preferred to drive continuous improvement and

Qualifications

• Bachelor's degree in an engineering discipline.
• Significant experience in manufacturing quality with leadership responsibilities.
• Knowledge of equipment, systems and quality improvement methodologies.
• Six Sigma certification is an advantage.

Responsibilities

• Oversee all quality processes and digital solutions related to QC management.
• Provide QC support for routine activities.
• Lead QC schedule and capacity planning for timely product releases.
• Define maintenance, qualification and calibration plans for lab equipment.
• Manage sample flows from sampling to dispatch to labs.
• Train QC samplers and maintain documentation.
• Coordinate external/cross-site testing and data reporting.
• Oversee stability studies and ensure timely reporting.

Skills

Leadership

Analytical skills

Problem-solving

Communication skills

Six Sigma

Education

Bachelor's degree in Electrical Engineering, Mechanical Engineering or Industrial Engineering

Tools

Quality management systems

Job description

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.