QP – Associate Director, GMDP Quality
Description
Drive Quality Excellence Across Europe
At Shionogi, we are committed to safeguarding global health through scientific innovation, operational excellence, and dedication to quality. As our European operations expand, we are strengthening our Quality organisation to ensure our products consistently meet the highest standards of GMP, regulatory compliance, and patient safety.
We are now seeking an qualified QP to join our Quality Assurance team. This position offers a unique blend of hands‑on QP responsibilities and broad manufacturing quality oversight.
Why Join Shionogi?
Shionogi offers an agile, collaborative, and purpose‑driven environment where quality is central to every decision we make. You will enjoy high levels of autonomy and the opportunity to significantly shape how Quality operates across Europe.
This role is initially a hands‑on position, ideal for someone who thrives in both technical depth and operational execution. Over time, this role is anticipated to progress into leading the small GMDP Quality team.
About the Role
As a QP for Shionogi, you will ensure products released to European markets comply with all relevant EU and the Netherlands regulatory requirements. While QP release is a key accountability, the majority of your time will be spent providing broader GMDP quality oversight, driving continuous improvement, and strengthening supply chain and manufacturing quality processes.
You will:
- Perform QP certification in accordance with EU Directives and applicable GMP requirements.
- Establish, manage, and continuously improve local GMP/GDP quality systems, including SOPs, training, document control, and quality manuals.
- Maintain strong quality oversight of CMOs, analytical laboratories, and logistics partners across Europe and Japan.
- Lead and support investigations, deviations, CAPAs, change controls, and quality system improvements.
- Support strategic quality projects, including inspection readiness and regulatory interactions.
- Deliver training and act as a trusted subject matter expert across the European Quality organisation.
What Are We Looking For?
We are seeking a driven, detail‑oriented Quality professional with a strong technical foundation and the confidence to work autonomously from day one.
You will bring:
- Eligibility to act as a Qualified Person (QP) under EU Directive requirements.
- Experience of autonomously performing QP responsibilities.
- Experience of GMP Quality Assurance across manufacturing, analytics, or supply chain.
- Strong knowledge of EU GMP/GDP guidance and quality regulations.
- Experience with deviations, investigations, audits, CMOs, and technical agreements.
- A hands‑on, proactive approach with strong problem‑solving and organisational capability.
- Team‑leadership or supervisory experience, or a clear readiness to grow into a leadership role.
Join Us
Join Shionogi and play a key role in shaping the future of Quality across Europe. In this impactful position, you will ensure the highest standards of product quality and patient safety while building the foundation for future leadership of the GMDP Quality team.
If you are passionate about Quality, motivated by both technical excellence and future leadership, and ready to make a meaningful impact, we encourage you to apply.