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Quality Assurance Manager

Australia & NZ · Full time

About The Position

Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.

As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live. Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve.

We are a dynamic, fast-paced company, operating in over 30 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us!

The QA Manager for Australia and New Zealand is an experienced quality professional and a key member of the Australian team. Based in Sydney, this role supports both Australia and New Zealand operations and reports directly to the Director, Tech Ops, APAC. The QA Manager plays a vital role across multiple business functions.

Responsibilities

  • Participate in designing, implementing, maintaining, and improving the local and global Quality Management System (QMS).
  • Ensure the local QMS is compliant, effective, and supports local business needs.
  • Independently initiate and approve SOP updates and create new SOPs; oversee SOP review cycles.
  • Provide hands-on quality expertise to colleagues and partners.
  • Participate in vendor management, oversight, QTA creation, and conduct/lead audits.
  • Work with the Tech Ops team to ensure compliance with GDP and GMP requirements.
  • Support and ensure self-inspections are completed and CAPAs closed on time.
  • Participate in Management Reviews to evaluate QMS effectiveness and identify improvements.
  • Support GDP vendor management reviews and partnership with distributors.
  • Review change controls, deviations, complaints, and CAPAs using risk-based principles.
  • Participate in regulatory inspections and supplier audits.
  • Manage local recall activities and participate in global mock recall operations.
  • Perform additional duties as assigned by management.

Requirements

  • Bachelor’s degree in science or equivalent.
  • 3–5 years of QA experience.
  • Excellent written and verbal communication skills; fluent English essential.
  • Strong attention to detail.
  • Experience representing quality in cross-functional projects.
  • Strong root-cause analysis and investigation skills.
  • Skilled in technical report writing.
  • Strong knowledge of regulatory, cGDP, and cGMP requirements.
  • Experience in auditing and quality systems; regulatory inspection experience desirable.
  • Strong critical-thinking and problem-solving abilities.
  • Collaborative, self-directed, and independent working style.
  • Strong organizational skills with the ability to build professional, trusting relationships.
  • Agile and effective in dynamic environments.
  • Willingness to travel locally and internationally.
  • Ability to influence across organizational levels and manage conflict professionally.
  • Quick learner with strong work ethic and pragmatic mindset.
  • Ability to identify problems, risks, and opportunities and propose viable solutions.
  • Able to work in a fast-paced environment and adapt to shifting priorities.