Quality Manager
We're Hiring: Quality Manager (m/f/d) | Clinical-Stage Biotech | Europe-Based (Remote/Hybrid Options Available)
Are you ready to play a pivotal role in shaping the future of healthcare innovation?
A cutting-edge biotech company on the brink of clinical entry is looking for a Quality Manager to help build and lead a next-generation Quality Management System (QMS). This is a unique opportunity to contribute to the global rollout of transformative injectable imaging agents and point-of-care technologies that are set to redefine hospital diagnostics.
🔍 What You'll Do:
- Partner with senior leadership to design and implement a robust, risk-based cGxP QMS from the ground up.
- Drive quality excellence across the full product lifecycle-from development and manufacturing to distribution and point-of-care use.
- Lead internal audits, support regulatory inspections, and manage supplier qualification and oversight.
- Champion a culture of proactive quality and continuous improvement across cross-functional teams.
- Act as the go-to expert for QMS operations, training, and eQMS administration.
🎯 What We're Looking For:
- 5+ years of hands-on QA experience within the EU.
- Strong knowledge of GMP and EU regulatory frameworks; FDA experience is a plus.
- Experience with short-shelf-life or point-of-care products (e.g., radiopharmaceuticals, ATMPs) is highly desirable.
- Proven track record in setting up and optimizing cGxP systems and managing third-party vendors.
- Fluent in English and German, with excellent communication and problem-solving skills.
- A self-starter mindset-comfortable in a fast-paced, innovative, and international environment.
💡 If you're passionate about quality, thrive in a startup-like setting, and want to make a real impact on global healthcare, we'd love to hear from you.
📩 Apply now or reach out directly for a confidential conversation.
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