Senior GCP/GCLP Quality Auditor (Remote)
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.
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.
Inclusion & Diversity
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.
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Senior GCP/GCLP Quality Auditor (Remote) employer: Ipsen Biopharm Ltd
Ipsen Biopharm Ltd is an excellent employer, offering a dynamic work environment in Wrexham where innovation and compliance are at the forefront of pharmaceutical manufacturing. Employees benefit from a strong commitment to health and safety, opportunities for professional growth, and a culture that values continuous improvement and teamwork. Joining Ipsen means being part of a dedicated team that plays a crucial role in delivering high-quality drug substances while enjoying the support and resources needed to thrive in your career.
