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QA Manager

Job description

SHORT DESCRIPTION

We are looking for a fulltime experimented quality manager to contribute effectively to the continuous improvement of the QA department and satisfaction of the customers, which are research- based pharmaceutical or biotechnological companies with a drug pipeline in development phase (II or III).

REQUIREMENTS

  • Strong skills in Software as a Service environment and IT background
  • Proven track of managing organizational change and digital transformation
  • Good knowledge of the related regulations and standards
  • Experience in implementing and maintaining ISO quality systems
  • Experience in the pharmaceutical industry
  • Experience with medical HW (not qualified as medical device)
  • Good project management skills
  • Ability to handle priorities, stress and deadlines
  • Interpersonal skills and capacity to interact in a multi-disciplinary team
  • Ability to work under limited supervision
  • Fluent in English
  • Be open-minded, proactive and team player

RESPONSIBILITIES

  • Manage and further develop the quality management system
  • Support the operational team in quality records
  • Work with the related regulations and standards (ISO-9001, IEC 62304, 2006, GOOD
  • PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP” ENVIRONMENT, GDPR,
  • HIPAA, 21/CFR11, EU Annex 11)
  • Manage audits for customers and partners (Pharma, biotech, CRO, CMO)
  • Manage customers interaction regarding satisfaction and product quality
  • Collect, analyze, and report data to management
  • Taking part in strategic decisions related to QA and company success
  • Act as the company’s group ambassador, promoting our values

Contract

Executive search

Experience

Minimum 5 years

Education

Higher Education

Languages

English

Sector

Pharmaceutical industry

Region

Remote

Job Type

Full-time

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