Associate Director QA Operations & Systems QA AUS

As Associate Director QA Operations and Systems, you will be responsible for establishing, maintaining, and developing Quality Assurance (QA) Operations and Systems teams and processes for the Australia (AUS) BioNTainer site. You will ensure implementation of GMP compliant operations and quality system at the site, and help to develop and ensure the Quality mindset of the organization and preserve compliance with national and international regulations.

Requirements

• 8+ years of relevant experience in a pharmaceutical industry, GMP/GDP experience.
• Working knowledge of TGA and PIC/S relevant regulations and guidelines.
• Experience in hosting inspections and collaborating with national or international regulatory agencies.
• Quality Operations experience across pharmaceutical GMP functions.
• Experience within a quality organization in supporting development of IMPs (vaccines, biologics and ATMPs) from early through late-phase clinical trials.

Benefits

• Competitive remuneration package