Qualified Person

Ipsen; Wrexham; On-site; GBP 70,000 - 110,000; Full time

Job summary

Ipsen Wrexham is seeking an experienced Qualified Person to lead regulatory compliance, batch release and quality systems on-site. You will be named on key licences and work across manufacturing, technical, and regulatory teams to ensure products meet UK/EU standards.

The role requires a strong quality mindset, leadership skills, and extensive GMP knowledge, with a focus on patient safety and continuous improvement at the Wrexham site.

Qualifications

• Degree 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.

Responsibilities

• 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.

Skills

Qualified Person eligibility

GMP knowledge

English proficiency

Pharma industry experience

Education

Degree in Chemistry/Pharmacy/Biology

Job description

Title: Qualified Person
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:

Join Our Award-Winning Team at Ipsen Wrexham

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

Essential:

• 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

#LI-Onsite

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace "The Real Us". The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.