Company

PentixaPharm GmbH is part of the Eckert & Ziegler Group, one of the world's largest manufacturers of radioactive components for medical, scientific and metrological purposes. The company focuses on applications in cancer therapy, industrial radiometry and nuclear medicine diagnostics. PentixaPharm's operations are divided into the clinical development and chemical manufacturing of PentixaFor and PentixaTher, an innovative pair of theranostics that specifically target the CXCR4 receptor found in most rapidly progressing diseases, including hematologic and solid cancers and cardiovascular malignancies. PentixaPharm employs 20 people at its sites in Berlin and Würzburg.

Your tasks

• Support the maintenance and optimization of the quality management system, implementation and maintenance of quality assurance agreements, creation and review of quality management documents and updating of trackers.
• Coordination of all relevant tasks related to document management, changes, deviations, CAPAs, qualification, validation.
• Initiation and maintenance of processes to collect and report compliance and quality performance indicators.
• Preparation of training documents, execution of training courses.
• Analysis of compliance with training requirements.
• Participate in the planning and implementation of quality objectives.
• Process improvements, manage improvement proposals and participate in improvement projects.
• Assisting in risk management activities / conducting risk analysis.
• Responsibility for auditing service partners such as CROs and following up on resulting activities to ensure product compliance.

Your profil

• Degree in business administration or relevant field of study
• Certification for quality control is an advantage
• Advanced training in QM, process or project management preferred
• At least 3 years (5 years preferred) of professional experience in quality management or other production-related areas of medical technology
• Experience in data science tasks such as forecasting, data modeling and visualization, automation and business analytics
• Fluent in English and German (verbal and written)
• Strong knowledge of ISO 9001 requirements, preferably of ISO 15189 requirements GCP, GDP, GCLP and GMP
• Proactive, reliable and goal-oriented way of working
• Strong communication and persuasion skills
• Confident handling of MS-Office

Other Useful Information

• Specifics of the position: multi-disciplinary international project management
• Internal and external contacts (organisation): yes, with about 20% traveling
• People management:  managing diverse relationships
• Benefits:
  • Performance Bonus
  • 30 days of vacation
  • Exciting job opportunity with project responsibilities and freedom for professional growths and acquisition of new skills

If you want to become a part of our young and motivated team and if you are ready for a new challenge, we are looking forward to your complete application including your salary expectations - please send it to: anne.lobach@pentixapharm.com

We are looking forward to receiving your application!