Qualified Person

At Ipsen, we are driven by one purpose: improving patients’ lives through innovative medicines. Our Wrexham site plays a critical role in delivering high-quality sterile pharmaceutical products to patients across the UK and EU.

We are proud to be Great Place to Work® certified and a Shingo Bronze Medallion holder, reflecting our strong culture of excellence, continuous improvement and collaboration. With a £24m recent investment and a further £86.4m site expansion underway, there has never been a more exciting time to join Ipsen Wrexham.

If you are an experienced Qualified Person who is passionate about quality, leadership and making a real impact on patient safety, we would love to hear from you.

As a Qualified Person, you will be named on both the Ipsen Wrexham MIA and IMP licences and play a critical leadership role in ensuring that medicinal products are manufactured and released in full compliance with UK and EU regulatory requirements.

You will act as a key quality leader on site, supporting both commercial and clinical activities, driving a strong “Commitment to Quality” culture, and partnering closely with manufacturing, technical and supply teams to ensure compliant, timely batch disposition.

• Certify and release finished product batches in line with EU/UK GMP and Annex 16, in accordance with Quality Technical Agreements
• Confirm compliance of intermediate manufacturing stages, either personally or through collaboration with other Ipsen QPs
• Lead and support timely batch disposition for commercial and clinical products, escalating quality risks where required
• Provide quality leadership and expert input across manufacturing, product development and regulatory activities
• Drive continuous improvement initiatives to enhance compliance, efficiency and site quality performance
• Act as a subject matter expert during regulatory inspections, internal audits and partner interactions
• Serve as a key point of contact for CMO and affiliate GMP quality matters
• Mentor and support the Quality Operations team, acting as a role model for quality-first decision making

• Degree (or equivalent) in a relevant scientific discipline (e.g. Chemistry, Pharmacy, Biology, Biochemistry)
• Eligible to act as a Qualified Person under UK/EU regulations
• Significant pharmaceutical industry experience, ideally within sterile manufacturing and Quality Assurance
• Strong working knowledge of GMP requirements, including Annex 1 and Annex 16
• Fluent written and spoken English

• Previous experience being named on an IMP licence
• Strong sterile manufacturing expertise
• Lean, Six Sigma or other continuous improvement qualifications
• Lead Auditor qualification

• A strong patient and customer focus
• Confidence in mindful risk-based decision making
• The ability to operate effectively in ambiguous or complex environments
• A collaborative mindset, building strong partnerships across functions
• A genuine commitment to quality, integrity and continuous improvement

• Working style:
  Fully on-site
• Collaboration:
  
  Work closely with Manufacturing, QC, QA, MS&T and Supply Chain
• Culture:
  Inclusive, supportive and improvement-driven
• Impact:
  Direct contribution to patient safety and product quality

• Be part of a highly invested, expanding manufacturing site
• Work in an organisation recognised for operational excellence and people culture
• Influence quality strategy and decision making at site and global level
• Make a meaningful difference to patients' lives every day