Prothena

Associate Director, Quality Assurance GMP (EU)

Job Locations IE-Dun Laoghaire
Job ID
2018-1267
Category
Research & Development

Overview

The Quality Assurance function is an essential part of Prothena’s Quality Department, ensuring product manufacture and distribution in compliance with applicable EU, US and other international standards/regulations and best in class industry practice.  The position will be responsible to develop, optimize and maintain Quality Systems, procedures and documentation and to achieve operational Quality goals and targets. Specific focus will include management of inspection readiness and commercial readiness

deliverables within the GMP/GDP space.   

Responsibilities

  • Manage deliverables in support of Inspection readiness for QA GMP/GDP operations and ensure future QA commercial launch readiness
  • Develop, review and implement Quality SOPs supporting GMP/GDP activities
  • Provide QA support to Prothena stakeholder departments, including Technical Operations, and Affiliate offices, for GMP/GDP activities associated with clinical and commercial systems
  • Conduct Quality reviews and provide QA input to Contract Service Providers
  • Serve as QA reviewer for change controls, conduct Quality audits, track and follow up on audit findings and CAPA’s along with other QMS activities and tasks
  • Drive QA KPI/metrics performance and contribute to the Quality management review process
  • Lead reviews of CSP Quality Agreements, QA review of GMP/GDP qualification/validation activities and IT and data integrity reviews
  • Travel as necessary (ca. 5-10 %)

Qualifications

Education and Experience:

  • Bachelor’s degree in a health science or equivalent along with a postgraduate qualification
  • Qualified Person (QP) qualification to EU requirements
  • 10+ years of experience within the pharmaceutical, and/or preferably biopharmaceutical, industry; previous start-up experience of interest
  • 6+ years of experience within Quality including ca. 2-3 years licensing as QP, i.e., previously engaged in batch release under an EU Manufacturer/Importer’s Authorisation
  • Excellent knowledge of Quality/GxP legislation, including GMP/GDP regulations and guidelines
  • Other previous work experience, including within manufacturing/other key operational area(s) and/or GxP auditing experience would also be of interest

Competencies and Attributes:

  • Self-motivated individual with proven ability to optimise systems, develop future quality strategy and who will work in accordance with the Prothena core cultural values (creative, selfless, courageous and humour)
  • Team player, good communicator, flexible/adaptable with a hands-on approach
  • An individual who takes responsibility and pride in their work and is loyal, co-operative and decisive
  • Excellent attention to detail

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