QC Process Leader - Microbiology

QC Process Leader - Microbiology

Ipsen Pharma

Wrexham, United Kingdom

We 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 responsibilities:

• Lead 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 & experience:

• Degree 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.