Qualified Person

Location: Wrexham
Function: Quality Assurance Operations

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