Quality Control PCU manager (Incoming and Device)

(2491) Genzyme Ireland Limited; Waterford; On-site; EUR 73,000 - 98,000; Full time

Job summary

Sanofi Waterford is seeking a Quality Control PCU Manager (Incoming and Device) for a 12-month FTC. You will oversee daily QC lab operations, ensure GMP-compliant processes, and manage validation and training within a fast-moving biopharma environment.

The role requires a science/engineering degree, strong leadership, and experience in manufacturing quality. You will contribute to CAPAs, investigations, and regulatory support from the Waterford site.

Qualifications

• Bachelor's degree in science, engineering, industrial engineering, or related discipline.
• Significant relevant experience in manufacturing quality; managerial experience is a plus.
• Strong leadership, analytical, problem-solving, and communication skills.
• Six Sigma or equivalent quality certification is advantageous.

Responsibilities

• Oversee daily QC laboratory operations to meet scheduled plans.
• Maintain GMP-compliant lab and processes per internal/external quality requirements.
• Ensure validated methods are used and transfer protocols executed as receiving unit.
• Manage and train laboratory staff following safety guidelines.
• Maintain lab qualification matrix to ensure testing readiness.
• Conduct routine shopfloor reviews to identify improvements.
• Ensure accurate and timely testing of received samples.
• Review and approve laboratory test results and reports.
• Maintain lab equipment through maintenance, qualification, calibration plans.
• Follow up on investigations, change controls, and CAPAs in timely manner.
• Investigate quality events and implement remediation actions.
• Support regulatory inspections and audits with QC-related responses.

Skills

Leadership

Analytical

Problem solving

Communication

Six Sigma

Education

Bachelor's degree in Science/Engineering

Job description

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.

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. Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science.

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.

We are an R'D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.

Discover more about us visiting www.sanofi.com or via our movie. We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.