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CDMO Quality Manager – Pharma/GMP (m/f/d)

Dresden
Full or part-time
Temporary

Your chance with us

Would you like to become part of an internationally operating company in a future-proof industry? Due to our continued growth, we are offering an initial two-year fixed-term position in a modern working environment surrounded by greenery in Dresden, Germany (01328).
As a CDMO Quality Manager – Pharma/GMP (m/f/d), you can expect challenging responsibilities, flexible working-time models, and attractive benefits designed to support a healthy work-life balance.

More than just a job

  • An initial two-year fixed-term position in a future-oriented, internationally operating company
  • Flexible working-time models to support the compatibility of work and family life
  • 30 days of annual leave
  • 10 paid days of leave to care for a sick child
  • A modern workplace, including height-adjustable desks, in a green and peaceful environment
  • Free company parking and electric vehicle charging facilities
  • Three additional discretionary sick days
  • Access to a wide range of attractive benefits through our ROTOP Benefits Portal
  • Company bicycle leasing and a subsidized public transport pass
  • Team-building company events that strengthen collaboration and team spirit
  • Diverse career and professional development opportunities as well as additional benefits

Your tasks

  • Manage CDMO customer projects from a Quality Assurance and pharmaceutical quality perspective
  • Support technology transfers, product launches, and GMP-relevant process changes
  • Serve as the main contact for external CDMO customers regarding quality-related and regulatory matters
  • Review and approve manufacturing, testing, validation, and quality documents in compliance with GMP requirements
  • Process and assess deviations, OOS/OOT results, CAPAs, and change controls
  • Support batch release activities and prepare and maintain Quality Agreements
  • Plan, support, and follow up on customer audits, inspections, and quality-related actions

Your profile

  • A successfully completed degree in a natural science, such as pharmacy, chemistry, biology or biotechnology
  • Professional experience in pharmaceutical quality assurance, Quality Assurance or a GMP-regulated environment is an advantage
  • Knowledge of deviation management, CAPA, change control, OOS/OOT or batch documentation is desirable
  • A careful, precise, and GMP-compliant approach to work
  • A strong quality mindset and a good understanding of pharmaceutical processes and cross-functional interfaces
  • An independent and structured working style, combined with the ability to coordinate complex tasks effectively
  • Very good German and English skills for communication with internal departments and international customers

Your team

Become part of a growing team and help us shape the future. Apply now as a CDMO Quality Manager – Pharma/GMP (m/f/d) and take the opportunity to advance your career in a modern and international working environment.

If you would like to contribute your skills in an innovative environment and continue developing both professionally and personally, we look forward to receiving your application.

Please send your application by email to bewerbung@rotop-pharmaka.de, for the attention of Sven Schäfer, or apply directly online.

About us

We are ROTOP Pharmaka GmbH, a leading pharmaceutical manufacturer in Germany, headquartered in Dresden-Rossendorf. For more than 25 years, we have developed, manufactured, and supplied cGMP-compliant radiopharmaceuticals for diagnostics and therapy in nuclear medicine and molecular imaging – distributed to more than 40 countries worldwide.

The ROTOP brand stands for quality, reliability, and pharmaceutical expertise. As a radiopharmaceutical manufacturer, we focus on close customer relationships, collaborative partnerships, and tailored radiopharmaceutical solutions for hospitals, clinics, and research partners. Our mission: advancing the medicine of tomorrow – developed and manufactured with responsibility.

ROTOP Pharmaka stands for integrity, expertise, and commitment – from Dresden to the future of nuclear medicine.