Manager, Global Quality Engineering – Pharmaceutical Sector

Manager, Global Quality Engineering – Pharmaceutical Sector

This role is responsible for quality oversight of GMP compliant commissioning and qualification of utilities and production facilities, equipment, and cleanrooms for CAPEX and OPEX projects (local and global). This includes review and approval of all user requirements, risk assessments, protocols and reports related to commissioning and qualification activities.
Unrestricted Australian work rights required to be considered.

Main accountabilities and responsibilities:
  • Ensure GMP-compliant planning and implementation of projects in the area of Commissioning & Qualification.
  • Perform QA activities, including issue and risk management for local and global CAPEX and OPEX projects in the area of Commissioning & Qualification
  • Provide a consistent quality approach to utilities, production facilities, equipment, and cleanrooms, with attention to process design.
  • Ensure GMP compliant execution of commissioning and qualification activities in accordance with approved project plans within required timelines and in compliance with internal and regulatory requirements (EU, TGA, FDA)
  • Quality oversight and approval of risk analysis, user requirements (URS), factory acceptance testing (FAT), on-site acceptance testing (SAT), and DQ/IQ/OQ/PQ plans and reports as part of local and global CAPEX and OPEX projects
Experience required:
  • 5+ years of experience as a professional in the pharmaceutical industry or equivalent combination of education and experience.
  • Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, TGA, EU, and other regulatory agency guidelines and in manufacturing of biologics.
  • Direct experience in quality oversight of GMP-compliant commissioning and qualification of production facilities, equipment, and cleanrooms
  • Strong quality process knowledge
  • Experience in interacting with regulatory authorities including submissions and inspections.
  • Experience in working in a global environment.
  • Engineering experience is desirable.
  • In-depth knowledge of cGMP’s, FDA, TGA, EU and other relevant GxP regulations
  • Proficient in English. Additional language skill such as German are an asset.
  • Knowledge of auditing practices and procedures
  • Effective presentation and meeting skills within all levels of the organization and with external colleagues and collaborators

Degree in life sciences and/or engineering; Advanced degree preferred.

Should this opportunity align with your skills and experience please contact Dwayne Joyce on

Melbourne (Jacana)
Dwayne Joyce