Prothena

Sr. Director, Quality Head European Operations

IE-Dun Laoghaire
Job ID
2018-1260
Category
Research & Development

Overview

This position is accountable for the strategic leadership for GMP, GDP and Affiliate Quality operations in Europe. Responsibilities include Quality functions leading GMP and GDP operations and establishing the Quality operations needed to support the Commercial Affiliate offices.  

Responsibilities

  • Lead the strategy, implementation, and resource assessments required to provide Quality support to Affiliate Offices in Europe. These responsibilities include assuring the compliant build of Quality Systems, training, staffing, establishing QP and RP resources where required and successful management of related Health Authority inspections.     
  • Lead and strategically interface with the Quality team responsible for GMP and GDP oversite of CMO’s. Responsibilities include vendor interface, clinical and commercial product disposition activities and progressing the associated GMP and GDP elements of Prothena’s Quality Management System.  
  • Provide leadership and guidance in the development, reporting, and analysis of associated Quality metrics.
  • In conjunction with the Quality Head, promote an engaged quality culture across Prothena and contribute to management reviews taking into consideration GMP and GDP quality metrics, results of internal audits and external inspections, industry trends and the external regulatory environment.
  • Build and foster collaborative relationships with key stakeholders across the business.  
  • Provide leadership and guidance in the timely communication/escalation to the Quality Head and Management of issues associated with regulatory compliance.
  • Stay abreast of changes in European and FDA regulations, directives and guidelines and determine the impact on GMP, GDP and Affiliate operations and deliverables. Maintain comprehensive knowledge of applicable regulatory requirements and their interpretation.
  • Participate as a member of the Quality Leadership team fostering a compliant, efficient, effective Quality Management System supporting Prothena product development and commercial objectives.
  • Assure a state of compliance and readiness for Health Authority inspections and internal audits across GMP, GDP, and Affiliate functions.
  • Review clinical and commercial enabling regulatory submissions and facilitate responses to Regulatory Agencies for any inspection findings as required.
  • Build and lead a team of engaged quality professionals
  • Other duties as assigned
  • Travel ~25% as requested

Qualifications

Education and Experience:

  • Bachelor’s degree in a scientific discipline, with an advanced degree,
  • 10+ years of experience in the pharmaceutical industry; with 5+ years of experience directing multiple Quality Management functions and staff including such areas as; QMS leadership, GMP/GDP management, risk management, vendor management, inspection readiness and recruiting, managing and developing high-performance
  • Extensive experience implementing, interpreting, and providing guidance on applicable domestic and international regulations. Experience with GMP/GCP/ICH standards and regulatory guidance documents.
  • Strong cross-functional collaboration skills with emphasis on Project Management and Process Excellence.
  • Experience in directing and building Affiliate Quality functions.   

Competencies and Attributes:

  • Demonstrated leadership ability to drive results that are needed to achieve the company objectives in accord with the Prothena core cultural values of courageous, creative, selfless and
  • Demonstrated the ability to build trusted partnerships across the business furthering an engaged quality culture.
  • Demonstrated ability drive strategic decision making when presented with complex problems or deliverables.
  • Demonstrated ability to effectively collaborate and partner with functional management while maintaining an appropriate assertive style.
  • Well-organized and detailed oriented professional, with strong verbal and written communication skills.
  • Good computer skills with experience and working knowledge of MS Office (Word and Excel, Access, Adobe Acrobat professional).

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