QA Validation CMO Manager

This innovator is a global pharmaceutical company focused on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. With offices and facilities in the US, South America, Asia and Europe (Ireland), this organisation develops and commercialises innovative biopharmaceuticals for serious, life-threatening rare diseases and medical conditions. Core business and research is in enzyme replacement therapies. With over 3000 employees globally and circa 400 in Ireland, this organisation has seen steady expansion here in Ireland in the last 3 years across both site and virtual operations. As a result of further expansion, a new position has arisen for a QA Validation CMO Manager.

The Position:

  • Perform process validation activities related to biologic/small-molecule Drug Substance and Drug Products, specifically in the CMO environment.
  • Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions to meet the company and Agency requirements.
  • Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
  • Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
  • Determine methods and procedures on new assignments with oversight from manager .Oversee and manage the activities of sub-teams.
  • Maintain current knowledge of industry standards and regulatory requirements for products developed and manufactured by the business, validation techniques/approaches and systems utilised at the company.
  • Lead and represent QA Validation in multi-departmental meetings & project teams owned by QA.
  • Identifies and implements improvements to the QA Process Validation systems (department level impact).
  • Generation of process validation master plans, core validation master plans and additional supporting documentation.
  • Coordination of process validation activities performed at multiple locations including contract laboratories, contract manufacturing/testing facilities and internal laboratories.
  • Coordinate process validation activities involving cross-functional, multi-departmental teams including: Manufacturing (contract), Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.

The Person:

  • 7+ years’ experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
  • 1+ years’ experience in a position utilising formal project management a plus.
  • Experience with Fill/Finish processes including aseptic filling and lyophilisation.
  • Organisational and management skills to coordinate multi-discipline project groups
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations.

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

Salary: On Application Location: Dublin City Centre