At a Glance
- Tasks: Lead quality assurance and ensure compliance in pharmaceutical manufacturing.
- Company: Ipsen Biopharm Ltd, a global biopharmaceutical leader focused on transformative medicines.
- Benefits: Competitive salary, career growth, and a supportive workplace culture.
- Other info: Join a dynamic team committed to continuous improvement and operational excellence.
- Why this job: Make a real impact on patient safety and product quality every day.
- Qualifications: Degree in a scientific discipline and experience in pharmaceutical quality assurance.
The predicted salary is between 56700 - 69300 £ per year.
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 endeavour 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 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.
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: At Ipsen, how we work is just as important as what we deliver. We are looking for someone who demonstrates:
- 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.
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.
At Ipsen, each employee makes a real impact. Our teams are passionate about what they do because they care about making a difference in patients' lives. We invest in our employees to support life‑changing projects that create positive impact for patients and society.
Qualified Person in Wrexham employer: Ipsen Biopharm Ltd
Ipsen Biopharm Ltd is an exceptional employer, offering a dynamic work environment in Wrexham where innovation meets reliability. With a strong focus on employee growth and development, you will have the opportunity to enhance your skills while contributing to cutting-edge pharmaceutical manufacturing. The supportive culture and commitment to continuous improvement ensure that every team member plays a vital role in maintaining the highest standards of safety and efficiency.
StudySmarter Expert Advice🤫
We think this is how you could land Qualified Person in Wrexham
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Ipsen Biopharm Ltd. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Ipsen Biopharm Ltd.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Ipsen Biopharm Ltd. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Ipsen Biopharm Ltd is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Qualified Person in Wrexham
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Ipsen Biopharm Ltd!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Ipsen Biopharm Ltd that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Ipsen Biopharm Ltd!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Ipsen Biopharm Ltd, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Ipsen Biopharm Ltd
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Ipsen Biopharm Ltd that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Ipsen Biopharm Ltd’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
