We wish to appoint a Quality Operations Manager to join our QA CMC team establish a high level of compliance across our portfolio. You will focus on cGMP compliance of CMOs in Europe and other territories to ensure GMP adherence. Conduct of GMP/GDP audits of CMOs will form an important part of the role and could take up to 25% of your time. • Science degree in a relevant scientific discipline or greater than 10 years relevant industry experience • At least 5 years’ experience in an operations or quality role within sterile pharmaceutical manufacturing; experience in radiopharmaceutical production would be an advantage • Trained auditor with experience of auditing manufacturing sites • Comprehensive knowledge of EU GMP guidelines and good knowledge of EU and US FDA regulations • Experience preparing, revising SOPs and QMS activities • Experience with RA inspection processes • Experience writing and/or reviewing eCTD Module 3 documents would be an advantage