QC Process Leader

1 week ago

Wrexham, United Kingdom Ipsen Full time

At Ipsen, we are committed to improving the lives of patients, with a special focus on advancing neuroscience therapies. Our Wrexham site is a vital part of this mission, delivering cutting-edge solutions in a dynamic and collaborative environment. We are proud to be Great Place to Work certified and a Shingo Bronze Medallion holder, reflecting our commitment to excellence, innovation, and continuous improvement.With a recent £24 million investment in the site and a further £86.4 million expansion underway, there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth, innovation, and excellence, then Ipsen could be where you thriveWe are seeking an experienced Microbiologist to lead our QC Microbiology team as QC Microbiology Process Leader . This role is pivotal in ensuring regulatory compliance, operational excellence, and continuous improvement within a cGMP environment. You will manage a team of 17, fostering a culture of accountability, adaptability, and technical expertise while delivering high-quality microbiological testing services.Key ResponsibilitiesLead and develop the QC Microbiology team, ensuring timely delivery of testing services and compliance with regulatory standards. Oversee scheduling, resource allocation, and project timelines to optimize efficiency and performance. Manage investigations (OOS, OOT, OOE), change controls, and quality events, driving continuous improvement. Provide technical expertise for microbiological testing, regulatory submissions, and inspections. Maintain validated microbiological methods and monitor KPIs to enhance service quality. Support audits and ensure adherence to GMP and EHS requirements. Knowledge, Skills & ExperienceDegree in a relevant life sciences subject or equivalent experience Experience in cGMP regulated Microbiology laboratory (pharmaceutical or biopharmaceutical) Thorough understanding of Microbiological testing e.g. bioburden, endotoxin, sterility and environmental monitoring. People management experience You’ll play a critical role in safeguarding product quality and patient safety while shaping a high-performing team in a dynamic environment. Ready to make an impact? Apply now and help us deliver excellence in microbiological quality control.

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