About the position
We, Plumino Precision Fermentation Europe GmbH, are looking for a hands-on, commercially aware Qualified Person who is ready to step beyond daily batch release. You will act as the operational backbone of our Quality unit — owning topics independently, mentoring team members, and preparing to take over as Head of Quality in the medium term. Every other year, you’ll travel to support regulatory inspections and supplier audits.
Your Key Responsibilities
Act as EU-QP (or local equivalent) for batch certification and release of microbiologically derived API products from our sister company plant in Shanghai
Manage quality systems (Deviation, CAPA, Change Control, Complaints) with minimal supervision
Lead internal and external audits and represent Quality during authority inspections
Drive continuous improvement and digitalization of QMS processes
Deputize for the Head of Quality in management meetings and strategic projects
Travel internationally for approx. 2–3 weeks every other year (e.g., to supplier sites, or for group QA alignment meetings)
Your Profile
QP eligible (formal training and at least 2–3 years of independent QP release experience
Solid background in Pharma – GMP, GDP, ICH, and regulatory requirements
Proven ability to work autonomously: You don’t wait for instructions; you analyze, decide, and escalate wisely
Leadership potential: You have informally led projects or small teams and are eager to grow into a department head role
Willing and able to travel every other year (valid passport, no restrictions)
Language: Fluent in English and German
The following qualifications and experiences are considered advantageous but not required:
- Proficiency in Chinese (written or spoken)
- Working knowledge of REACH regulations
- Experience in the food sector (GMP/GHP context)
- Familiarity with cell culture media requirements
- Hands-on experience with Computerized System Validation (CSV)
- Oversight or close collaboration with Supply Chain functions
- Familiarity with amino acids or fermentation
What Makes This Role a Great Next Step
Possible development to Head of Quality Unit
No micromanagement: We want you to own quality topics end-to-end
Working in an international team
Travel is infrequent and planned far in advance
We Offer
Competitive salary
Performance-based bonus
Flexible working hours / hybrid option
Job Type: Full-time
Pay: 80.000,00€ - 100.000,00€ per year
Work Location: In person
