JOB DESCRIPTION

Position 
Job title: Quality Manager
Location: Berlin or Würzburg (Germany)

Company

PentixaPharm is a young radiopharmaceutical company with a small agile team of highly qualified employees committed to develop the innovative theranostic pair PentixaFor and PentixaTher specifically targeting the CXCR4-receptor expressed in most fast progressing diseases such as hematological and solid cancers as well as cardiovascular malignancies.

Purpose of the Position

  • Responsibility for the safety and operational standards within the clinical and CMC department.
  • Control of quality tasks within the departments and related tasks performed by affiliates, license partners and CROs.

Main Responsibilities and Tasks 

  • Being responsible for auditing of service partners such as CROs and the follow-up of any resulting activities to ensure product compliance
  • Support the maintenance and optimization of our Health Care Quality Management Systems incl. the implementation / maintenance of quality assurance agreements
  • Corresponding coordination of all relevant tasks related to document management, change, deviations, CAPAs, qualification, validation as well as health authority inspections is within your responsibility as well
  • Initiate and maintain processes for collecting and reporting compliance and quality performance indicators
  • Set up training documentation, execute trainings or provide guidance for Compliance & Quality topics with a focus on Sourcing
  • Analysis of training compliance
  • Analysis of key performance indicators
  • Preparation of annual quality report
  • Participation in planning and implementation of quality targets
  • Proposal for process improvements, management of improvement proposals and contribution to improvement projects
  • Support in risk management activities / conduct of risk analysis

Experience / Qualifications

  • Ideal: Qualification/degree and significant Industry expertise in Research and Development of investigational products and/or drug development
  • Minimum: 3-4 years of professional experience in the health care industry, preferably in Quality Management and already gained experience in further areas
  • Languages: Fluent English and German
Required Competencies
  • Proven qualification in auditing CROs
  • Good knowledge of Microsoft Office suit
  • Strong knowledge in ISO 9001 requirements, preferably ISO 15189 requirements GCP, GDP and GCLP
  • Leadership / Willingness to lead, take charge, and offer opinions and recommendations especially with regards to working in multidisciplinary teams in a complex global environment
  • Innovation / being proactive, creative and demonstrating alternative thinking to develop new ideas and solve problems quickly

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!