Qualified Person

Ipsen; Wrexham; On-site; GBP 85,000 - 105,000; Full time

Job summary

Ipsen Wrexham is seeking an experienced Qualified Person to join our on-site quality leadership team. You will be named on the Ipsen Wrexham MIA and IMP licences and ensure medicinal products are manufactured and released in full compliance with UK/EU regulations.

You will lead batch disposition, advise on quality risk, mentor the QA/Quality Operations teams, and partner with manufacturing, technical and regulatory colleagues to uphold patient safety and product quality.

Qualifications

• 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.
• Lean Six Sigma or other continuous improvement qualifications.
• Lead Auditor qualification.

Responsibilities

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

Skills

Qualified Person eligibility

GMP knowledge (Annex 1 & 16)

Sterile manufacturing experience

Fluent English

Education

Degree in a relevant scientific discipline

Tools

Lean Six Sigma

Lead Auditor qualification

Job description

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.

Role Summary

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.

In This Role You Will

• 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

What We’re Looking For

• 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

Desirable

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

What We Value

• 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 at Ipsen Wrexham

• 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

Why Join Ipsen?

• 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