Quality Systems Specialist

vor 1 Woche

Ulm, Baden-Württemberg, Deutschland NVision Imaging Technologies Vollzeit 60.000 € - 90.000 € pro Jahr
Your mission

We are searching for a Quality Systems Specialist (m/f/d) to support the establishment and management of an innovative pharmaceutical Quality Management System (QMS). 
Key Responsibilities:
Reporting to the Senior Director of Quality, you will:

Coordinate and manage the daily operation of the QMS in compliance with GxP, regulatory, and internal standards.Implement and manage a system of QMS metrics and measuresServe as the principal point of contact for all QMS-related matters.Support the development, implementation, and continuous improvement of the QMS, ensuring alignment with applicable regulations.Oversee and coordinate core quality processes, including Document & Training Management, Supplier & Audit Management, Change Controls, Deviations, CAPAs, Self-Inspections, Complaints, and Risk Management.Apply a risk-based approach and maintain the Quality Risk Register.Prepare, review, and maintain quality policies, SOPs, and related documentation.Support the rollout and training of the QMS and the implementation of an eQMS (including system administration).Conduct self-inspections and ensure continuous improvement initiatives are embedded.Support and foster a strong Quality Culture:
  • Provide cross-functional quality support in the design and implementation of processes as part of the QMS 
  • Deliver training and guidance on quality topics.
  • Support quality investigations and Quality Management Reviews.
  • Represent Quality in projects impacting the QMS.Your profile
  • At least 3 years of hands-on experience in quality assurance in a GMP environment.
  • Demonstrated experience in the development and continuous improvement of cGMP quality systems.
  • Excellent problem-solving, analytical, and communication skills.
  • Familiarity with electronic Quality Management Systems (eQMS).
  • Fluent in English.Why us?
  • Competitive compensation, based on base salary and stock options 
  • Hybrid working model
  • Key role in a highly advanced and fast-growing startup company 
  • Ample opportunity for personal initiatives, openness to new ideas and room for considerable personal impact
  • Impactful product promoting better understanding and treatment of disease
  • International team, from over 20 different nationalities
  • Enjoyable work atmosphere with an open-door and open communications mentality
  • Indefinite employment contract, providing stability
  • Long-term career growth opportunities 
  • 30 vacation days
  • Relocation supportcontact information

Join us in making a difference Submit your application to be considered for this exciting opportunity. 

Any questions? Please contact: 
Sandra Schärli
Senior Talent Acquisition Manager 
mail: -

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