Quality Management Specialist

vor 24 Stunden


Frankfurt am Main, Hessen, Deutschland Scienta Vollzeit
Director of Quality Job Description

(Sr) Director of Quality Scienta –

Scienta are pleased to be partnering with a leading CDMO in the search for their new (Sr) Director of Quality.

Your Role

  • Creation, review and maintenance of training plans for the Quality Systems and Compliance Team
  • Responsible for main QMS processes at the site, including document management, change control, qualification and validation, IT validation, GxP training, deviation investigations and CAPA process
  • Applying relevant quality management procedures and regulations, incorporating requirements into local processes to ensure compliance with internal and regulatory standards
  • Work closely with Global Quality to ensure proper flow of information to and from the site
  • Responsibility for functioning communication and escalation process on product quality in accordance with requirements and coordination of on-site investigations
  • Observation and interpretation of quality KPIs at the site, proposing improvement measures
  • Conducting customer audits and regulatory inspections, including preparation, participation and follow-up, as well as responsibility for and conduct of self-inspections
  • Responsibility for and implementation of PQR management, CPV process and other trend activities
  • Oversee the Quality department, strategy, budget and hires (approximately 90 FTE)
Requirements
  • 5+ years experience in large team management (10 direct reports and up)
  • Relevant scientific education/degree
  • 10+ years GMP experience
  • Experience in a dynamic, fast-paced environment with client-facing interactions
  • German and English required


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