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.

Requirements

• University degree (e.g., Bachelor’s degree) in relevant scientific discipline, and additional qualifications (MSc, MBA) are advantageous.
• 8+ years of relevant experience in a pharmaceutical industry, GMP/GDP experience.
• Working knowledge of TGA and PIC/S relevant regulations and guidelines (experience with ICH, US FDA, EMA, etc. are advantageous).
• Experience in hosting inspections and collaborating with national or international regulatory agencies.
• Quality Operations experience across pharmaceutical GMP functions (additional experience within a technical quality function is desirable)
• Experience within a quality organization in supporting development of IMPs (vaccines, biologics and ATMPs) from early through late-phase clinical trials is highly advantageous.
• Strong solution driven mindset and desire to learn.
• Ability to conceptualize, analyze, plan and manage in a fast-paced environment.
• Ability to be agile, effectively collaborate, and build consensus in a dynamic, cross-functional environment.
• Excellent interpersonal skills; outstanding communication skills (verbal and written).
• Ability to navigate through ambiguity and rapid growth and adapt to change.
• Experience leading team/budget.
• Fluency in English (written and spoken) is essential.

Benefits

• Competitive remuneration package
• Variety of benefits in support of diverse employee base