Quality Control PCU manager (Incoming and Device)

Job Title: Quality Control PCU Manager (Incoming and Device)

• 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 daily operations of the quality control laboratory to ensure adherence to the committed scheduled plans
• Maintaining his/her laboratory in compliance with the GMPs and quality control processes defined according to internal and external quality requirements and regulations
• Ensuring the use of validated methods in his/her perimeter and executing any validation/transfer protocol as receiving unit
• Managing and training laboratory staff, ensuring they follow best practices and safety guidelines
• Ensuring his/her laboratory staff is qualified to perform the testing execution by maintaining the lab qualification matrix
• Conducting routine shopfloor of laboratory to identify improvement opportunities
• Ensuring accurate and timely testing of received samples according to his/her perimeter
• Reviewing and approving laboratory test results and reports
• Maintaining laboratory equipment by applying maintenance, qualification, and calibration plans to ensure accuracy and reliability of lab activities
• Ensuring the follow-up and progress of the investigations, change control, and CAPAs assigned to his/her perimeter, in a timely manner
• Investigating in a timely manner and resolving any quality control events, issues, or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs
• Providing support during regulatory inspections and audits by answering to requests related to his/her perimeter
• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately

About you

• Bachelor's degree in science, Engineering, Industrial Engineering, or a related discipline.
• Significant relevant experience in manufacturing quality, including demonstrable experience in managerial or leadership role is an advantage.
• 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.