At a Glance
- Tasks: Lead GCP/GCLP audits and ensure compliance with regulatory standards.
- Company: Ipsen, a global biopharmaceutical company focused on transformative medicines.
- Benefits: Remote work, inclusive culture, and opportunities for professional growth.
- Other info: Join a diverse team committed to innovation and collaboration.
- Why this job: Make a real impact on patient safety and quality standards globally.
- Qualifications: Experience in GCP/GCLP auditing and Lead Auditor certification required.
The predicted salary is between 60000 - 75000 £ 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 us on our journey towards sustainable growth, creating real impact on patients and society!
Job Description
We are offering an exceptional opportunity to join a dynamic global team that is developing and enhancing Ipsen’s audit strategy. You will join a team that is responsible for the audits across all GxPs, a team that is passionate about Quality. As a Senior GCP/GCLP Quality Auditor, you will lead and manage audit activities in line with regulatory requirements, company policies and procedures. The role includes global travel to conduct audits and attend relevant meetings as needed.
What you’ll do:
- Lead and deliver a combination of risk‑based GCP/GCLP audits across internal and external partners
- Own audit planning, execution, reporting and CAPA oversight
- Act as a trusted subject matter expert, advising stakeholders and supporting regulatory inspections
- Coach and peer‑review auditors, contributing to continuous improvement of Ipsen’s audit framework
- Collaborate globally within our Global Quality Audit (GQA) team
What you’ll bring:
- Strong experience auditing one or more GCP/GCLP environments
- Lead Auditor certification and a scientific or health‑related background
- Confidence working independently in a global, matrix environment
- Excellent communication skills in English (French a plus)
- Flexibility to travel internationally (significant travel required)
Why Ipsen
You’ll join a values‑driven organisation where we Think Big, Act Together and Execute with Precision, with the opportunity to influence quality standards globally and safeguard patient safety. 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.
Senior Gcp/Gclp Quality Auditor employer: Ipsen
Ipsen in Wrexham is an excellent employer, offering a collaborative work culture that prioritises innovation and excellence. Employees benefit from a supportive environment with opportunities for professional growth, all while working in a state-of-the-art packing facility that operates on a convenient Monday to Friday schedule. Join us to be part of a team that values your expertise and contributions in mechanical engineering and vision systems.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Gcp/Gclp Quality Auditor
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Ipsen. 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.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Ipsen. 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 is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Gcp/Gclp Quality Auditor
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!
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 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!
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, 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
✨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 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’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.
