Manager of Quality Assurance

Client Ryvu
Location Kraków (Ryvu)
Offer description

As a Manager of Quality Assurance  you will play playing a vital role in the drug discovery projects in the field of quality management.

We are looking for Individuals having a solid experience in  quality assurance with the strong knowledge of Good Clinical Practice and who are ready to develop professional competences and contribute to R&D projects.

KEY RESPONSIBILITIES
  • Formulate GxP compliance strategy and provide advice for all drug discovery and development programs
  • Development, maintenance and continuous improvement and up-to-datedness of a Quality Management System (QMS)
  • Establishing of Quality Objectives within the organization and provide strategic leadership of QMS development
  • Lead the development and implementation of procedural documents (e.g. SOPs) at Ryvu.
  • Drive execution of QMS processes through programs, polices and functions that support corporate and product quality
  • Support specific departmental needs to maintain and improve QMS requirements for ongoing laboratory and other operational activities
  • In support of quality systems, provide effective leadership support, training and guidance to all company personnel
  • Oversight, planning and leading the internal and external audits/inspections and facilitation of development CAPAs
  • Support in vendor qualification, selection and oversight process relevant to GxP
  • Escalate identified issues and system gaps to executive management ensuring appropriate management oversight
  • Cooperate cross-functionally with internal departments on strategy development, risk assessments and implementation of quality principles and regulatory requirements
YOUR BACKGROUND
  • Minimum 5 years of experience in managing quality in GxP environment
  • Prior experience in biotech/pharmaceutical industry is expected
  • Experience in implementation and management of quality systems
  • Advanced understanding of drug discovery/development process is expected
  • Experience in audits and inspections
  • Knowledge of FDA, EU regulations as well as ICH guidelines

YOUR BENEFIT PACKAGE
  • Training program enabling scientific development: Peer to Peer Academy, scientific lectures, participation in conferences
  • Opportunity for rapid career development
  • Participation in challenging and ambitious projects
  • Package of benefits: private medical healthcare, Multisport Card, lunch subsidies, days with fruits, language classes refund
  • Possibility to take part in sports activities
  • Work in a dynamic Company with a high perspective of growth and operating in the innovative business sector
Last modified Tuesday, December 17, 2019