At a Glance
- Tasks: Ensure quality oversight for clinical studies and support compliance with regulations.
- Company: Ipsen Biopharm Ltd, a global biopharmaceutical leader focused on transformative medicines.
- Benefits: Empowering workplace culture, competitive salary, and opportunities for professional growth.
- Other info: Dynamic environment with a commitment to inclusion and diverse perspectives.
- Why this job: Join a passionate team making a real impact on patients' lives through innovative therapies.
- Qualifications: Significant experience in Clinical Quality Assurance and strong GCP knowledge required.
The predicted salary is between 63000 - 77000 £ 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're looking for an experienced Clinical Quality Assurance professional to join our Global Quality organisation. In this role, you'll partner with R&D, Global Medical Affairs, and cross-functional study teams to provide quality oversight and support across Ipsen's clinical studies and programmes. Acting as a trusted quality partner, you'll help ensure clinical activities are conducted in compliance with Good Clinical Practice (GCP), applicable regulations, and Ipsen quality standards. You'll also drive risk-based quality oversight, inspection readiness, continuous improvement, and quality excellence across our clinical development portfolio.
Key Responsibilities
- Provide quality oversight for clinical studies and programmes across multiple therapeutic areas.
- Partner with clinical and medical teams to ensure compliance with GCP, regulatory requirements, and Ipsen quality standards.
- Provide QA expertise and guidance to cross-functional study teams.
- Support quality planning, risk management, investigations, CAPAs, and quality improvement initiatives.
- Contribute to inspection readiness, regulatory GCP inspections, audits, and quality assessments.
- Support oversight of service providers, vendors, and clinical partners.
- Promote continuous improvement across clinical and medical quality systems and processes.
What We're Looking For
- Significant Clinical Quality Assurance experience within the pharmaceutical or biotechnology industry.
- Direct experience supporting GCP-regulated clinical studies and clinical development programmes (interventional and non-interventional clinical studies).
- Strong knowledge of Good Clinical Practice (GCP) and quality oversight principles.
- Experience supporting quality risk management, GCP inspections (e.g., MHRA, EMA, FDA), audit planning, investigations, and CAPAs.
- Ability to collaborate and influence effectively within a global matrix organisation.
- Master's degree or equivalent scientific qualification.
- Fluent English.
Why Ipsen? At Ipsen, you'll help ensure the highest standards of quality, compliance, and patient focus across our global clinical research activities while working alongside talented colleagues dedicated to bringing innovative therapies to patients.
Ready to Make an Impact? If you're a Clinical QA professional with strong GCP expertise and hands-on experience supporting clinical studies, we'd love to hear from you. Apply today and help shape the future of innovative medicines at Ipsen.
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 Manager QA Operations employer: Ipsen Group
Ipsen Group in Wrexham is an excellent employer that prioritises employee growth and development within the pharmaceutical manufacturing sector. With a strong commitment to innovation and excellence, employees benefit from a collaborative work culture that values safety and compliance, alongside opportunities for meaningful contributions to drug substance production. The location offers a supportive environment where team members can thrive and make a real impact in their roles.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager QA Operations
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Ipsen Group. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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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 Group.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Ipsen Group. 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 Group is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Manager QA Operations
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 Group!
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 Group 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 Group!
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 Group, 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 Group
✨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 Group 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 Group’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.
