Quality Systems Manager

2022-09-15 16:08:152050-02-20Team Horizon
Job TypeContractor
LocationDublin
AreaDublinDublinIrelandDublin
SectorQuality
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref#1002603
Job Views125
Description
Quality Systems Manager – Team Horizon
 
We are currently recruiting an ambitious Quality Systems Manager (Initial 9-month contract) to be part of our client’s team who are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader.
 
Reporting to the Director of Quality Systems, this role will interface globally with users across Operations, Commercial, Research & Development, IT and Quality to support execution and monitoring of the enterprise Quality Management System (QMS). The successful candidate will be based onsite and will provide leadership in a global matrix environment. There are no direct reports for this role.
 
Why you should apply:
  • Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
  • The role is generously compensated and attracts a competitive base salary.
  • Excellent career progression opportunities.
 
What you will bedoing:
  • Provide tactical and operational support to the Laboratory Investigation Report (LIR) Business Process Owner, including but not limited to, stakeholder management, process improvement execution, communication, technical writing and learning program development.
  • Facilitate User Communities, and collaborative workshops to share information, drive continuous improvement and brainstorm new ideas.
  • Lead and support projects related to LIR, including QMS integration and continuous improvement endeavours.
  • Use deep process knowledge and experience to assist business partners with the creation, review, approval, closure, and monitoring of quality systems records and associated quality risk assessments in compliance with internal and external requirements.
  • Proactively identify risks, issues, and best practices within the QMS.
  • Collaborate with global stakeholders to identify, plan and lead implementation of value-added improvements to the QMS.
  • On-time completion of assigned projects.
  • Author, review and approve QMS procedural documentation and working practice documents.
  • Participate in inspection readiness activities and internal/external audits and inspections.
  •  Other duties as required to support the growing Quality organization.
 
What you need to apply:
  • Bachelor’s degree in a healthcare or life sciences discipline (Chemistry, Biology, Biotechnology).
  • 8 years’ experience in a Quality role within the pharmaceutical industry, including prior experience having direct responsibility for the content and/or quality oversight of LIRs.
  • Expert knowledge of Phase 1 / Phase 2 OOS investigations for drug and device.
  • Demonstrated critical thinking and problem-solving skills.
  • Prior experience within a global matrix environment across multiple time zones, including workshop facilitation.
  • Prior experience training and coaching for skill development.
  • Excellent communication skills with all levels of the organization and Health Authority representatives.
  • Able to prioritize and manage workload and manage shifting priorities based on criticality to ensure commitments are met.
  • Prior experience in a combination product company strongly preferred.
  • Prior experience conducting audits preferred.
 
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Darcy Ainscough-Denton
Recruitment Consultant
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