Quality Manager (m/w/d)

EPM Scientific; Ulm; Hybrid; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

A leading biotech company is seeking a Quality Manager to establish a next-generation Quality Management System (QMS). This pivotal role involves driving quality excellence across product lifecycles, ensuring compliance with EU regulations, and fostering a culture of continuous improvement. Ideal candidates will have extensive QA experience, strong knowledge of GMP, and fluency in English and German.

Qualifikationen

• 5+ years of hands-on QA experience within the EU.
• Strong knowledge of GMP and EU regulatory frameworks.
• Fluent in English and German.

Aufgaben

• Design and implement a robust, risk-based cGxP QMS.
• Drive quality excellence across the full product lifecycle.
• Lead internal audits and manage supplier qualification.

Kenntnisse

Quality Assurance

Problem Solving

Communication

Continuous Improvement

Jobbeschreibung

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Recruitment Consultant - Life Science - QA/RA and R&D

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing

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