Title: QA Specialist - New Facility Company: Ipsen Biopharm Ltd About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram. Job Description: 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 thrive! Want to get involved in the expansion? We’re looking for a QA Specialist to support the launch of a brand-new drug product facility on our Wrexham manufacturing site. This facility is a major step forward in our pharmaceutical capabilities, and you’ll play a key role in bringing it online from a quality perspective. Your mission: ensure all documentation, processes, and systems meet GMP standards and are ready for operational excellence. What You’ll Do: Provide QA oversight for documentation and processes during the NDP facility set-up and beyond Support batch record review and ensure timely, compliant batch release. Lead investigations into deviations, OOS, CAPAs, and change controls. Deliver training and guidance on GMP and quality standards across teams. Represent QA in site projects and regulatory inspections. Drive continuous improvement and promote a proactive quality culture. What We’re Looking For: Experience in a similar role in pharma or biopharma. Strong knowledge of GMP, validation, and regulatory requirements. Experience in sterile manufacturing environments and batch release is highly preferred. Apply now and be part of a milestone moment in pharmaceutical manufacturing at our Wrexham site. LI-Onsite IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.