Quality Director

Your new company At Hays Specialist Recruitment, we have a great opportunity for a Quality Director Analytical CMC Life cycle to join our Biopharmaceutical client in Dublin on an initial 12-month contract. The role will contribute scientific and regulatory leadership across assets, with responsibilities spanning analytical methods, specifications, reference standards, and comparability approaches. Key deliverables include authorship of high-quality regulatory documents (e.g., justification of Specifications, analytical comparability protocols / reports, scientific briefing packages, responses to health authority questions) and providing subject matter expertise in analytical control strategies. Your new role Develop and execute analytical CMC strategy for late-stage assets transitioning to commercialisation. Provide scientific expertise in the lifecycle management of analytical strategies across commercial products, including specification setting, method lifecycle management, reference standards, and comparability studies. Serve as a subject-matter expert in analytical sciences, advising on cross-functional matrix teams and ensuring alignment with regulatory expectations. Partner effectively with Analytical Development, Quality, Regulatory, Process Sciences, Manufacturing, and Project Management to ensure strategies are executed with high scientific rigour and regulatory success. What you'll need to succeed A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 15+ years of biologics experience within an analytical CMC / relevant field, respectively. Extensive knowledge and hands-on experience in analytical CMC for biologics, including : O Specification setting O Analytical comparability strategy and risk assessments O Method lifecycle and change control O Reference standard strategy Proven track record of independently authoring complex regulatory and scientific documents (e.g., JOS, comparability reports, method validation summaries, regulatory responses). Demonstrated ability to provide strategic input into regulatory submissions (IND, BLA, NDA, ROW, PAS) and manage health authority communications (IRs, FUMs, PMCs). Strong technical writing and communication skills, with the ability to translate complex science into clear, compelling regulatory language. Highly skilled in leading, working within and influencing matrix teams; proven ability to drive alignment across functions without direct authority Solid understanding of analytical methods commonly applied to biologics (iCIEF, UPLC, CE, Bioassay, ELISA, LC-MS, etc.). In-depth knowledge of FDA and international regulatory guidelines and standards as well as extensive experience supporting Health Authority inspections. Extensive knowledge and hands-on experience in analytical CMC for biologics, including : o Specification setting o Analytical comparability strategy and risk assessments o Method lifecycle and change control o Reference standard strategy Proven track record of independently authoring complex regulatory and scientific documents (e.g., JOS, comparability reports, method validation summaries, regulatory responses). Strong technical writing and communication skills, with the ability to translate complex science into clear, compelling regulatory language. Highly skilled in leading, working within and influencing matrix teams; proven ability to drive alignment across functions without direct authority Solid understanding of analytical methods commonly applied to biologics (iCIEF, UPLC, CE, Bioassay, ELISA, LC-MS, etc.). In-depth knowledge of FDA and international regulatory guidelines and standards as well as extensive experience supporting Health Authority inspections. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career. Hays Ireland is a trading division of Hays Specialist Recruitment (Ireland) Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be Benefits : 12-Month Contract