Quality Manager – Delivery Devices

This global healthcare company is one of the world’s leading generics and specialty pharmaceutical companies globally, providing products to customers in approximately 140 countries and territories with revenues exceeding 10B in 2016. The company maintains a broad and high quality product portfolio, which offers approximately 1,300 separate products and is regularly bolstered by an innovative and robust pipeline. With a workforce of more than 20,000, this business has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service. The company ranks among the top generics companies in several international markets and is one of the largest U.S based generics manufacturers in the world. Due to continued expansion at their Dublin offices, a new position for Quality Manager – Delivery Devices has arisen.

The Position:

  • Quality lead for Design reviews of Combination Products and Devices in conjunction with Device Development Team, Regulatory Affairs, R&D and Market Research Teams
  • Quality lead for risk benefit analysis for combination products/device programs
  • Manage Quality Combination Products SOPs
  • Ownership and preparation of Design Verification and Design Validation protocols/reports and risk and usability reports in support of Design History Files
  • Support and facilitate post-approval activities such as Device Design changes
  • Relationship management and regular communication with key medical device suppliers to facilitate development projects and supplier compliance with applicable device requirements
  • Clinic trial involvement, such as formula studies, blinding studies and pK studies
  • Drive Human factor studies that support regulatory submissions
  • Responsibility for Quality aspects of device engineering and change control through the lifecycle of the Combination Products/Device project
  • Oversight of device elements of complaints
  • Participate in joint quality & technical assessments (with Global Device Development) of suppliers and device partnes
  • Quality oversight for device manufacturing for pivotal manufacturing campaigns

The Person:

  • 5+ years in a Quality role within a Combination Products or Medical Device field
  • 3rd Level qualification in Science or related pharmaceutical discipline
  • Experience in medical device industry required a distinct advantage
  • Experience in Respiratory and Injectable drug-delivery devices preferable
  • Strong familiarity with ISO 13485, Quality Systems for Medical Devices & FDA QSR 21 CFR 820 required
  • Working knowledge of Design Control/Design History File requirements
  • Strong background in the application of ISO 14971:2012, Risk Management for Medical Devices, is essential

To learn more apply on line or call Shane Browne at HRM on +353 1 6321865.

Salary: On Application Location: Dublin City Centre