RA/QA Director

2 weeks ago

Sydney, New South Wales, Australia Aegros Full time $120,000 - $180,000 per year

Company Description

Aegros is committed to ensuring access to life-saving therapeutic plasma drugs as a human right. Utilizing our Australian-invented Haemafrac electroseparation process, we innovate to put patients first. Based in Macquarie Park, Sydney, our TGA GMP-approved plasma fractionation plant manufactures a hyperimmune immunoglobulin product against Covid-19 from convalescent plasma. We are preparing to register the product on the Australian Register of Therapeutic Goods (ARTG) and upgrading our facility to process 100,000 liters of plasma per year.

Role Description

This is a full-time on-site role for a RA/QA Director located in Sydney, NSW. The RA/QA Director will oversee regulatory affairs and quality assurance activities, ensuring compliance with global regulatory requirements. Day-to-day tasks include managing quality systems, conducting quality audits, overseeing quality control processes, and maintaining quality management standards. The Director will also work closely with cross-functional teams to support product registration, quality improvements, and regulatory submissions.

Qualifications

  • Quality Control, Quality Assurance, and Quality Management skills
  • Experience with Quality Auditing and Quality System management
  • Strong understanding of TGA, PICS, EMA & global regulatory requirements
  • Excellent leadership and team management abilities
  • Ability to work collaboratively with cross-functional teams
  • Bachelor's degree in a related field, advanced degree preferred
  • Experience in the pharmaceutical or biotechnology industry is a mudt withvexperiencevin Plasma Fractionation a plus
  • Strong problem-solving and analytical skills

  • Product Quality Assurance

    1 week ago

    Sydney, New South Wales, Australia Resmed Full time $80,000 - $120,000 per year

    The Product Quality function partners with Engineering and cross-functional teams to enable the efficient and compliant release of a diverse range of products.This role focuses on Delivery Excellence —driving the velocity of product releases in line with established strategies, while also contributing expertise to shape new strategies and improve design...

  • Product Quality Assurance

    1 week ago

    Sydney, New South Wales, Australia ResMed Full time $80,000 - $120,000 per year

    The Product Quality function partners with Engineering and cross-functional teams to enable the efficient and compliant release of a diverse range of products.This role focuses on Delivery Excellence—driving the velocity of product releases in line with established strategies, while also contributing expertise to shape new strategies and improve design...

  • Senior RA/QA Associate

    1 day ago

    Sydney, New South Wales, Australia Axia HR Full time $80,000 - $120,000 per year

    Your new company    An innovative pharmaceutical organisation that is over 30 years established here in Australia is looking for a Senior Regulatory Professional to join their dynamic and collaborative organisation. This opportunity is a 12-month fixed term position with view to permanency. Boasting a broad range of branded products across a range of...

  • Senior Quality Assurance Specialist

    1 week ago

    Sydney, New South Wales, Australia GN Group Full time $90,000 - $120,000 per year

    At GN Hearing, we're driven by a simple but powerful purpose: to make life sound better. As one of the world's leading innovators in hearing solutions, we combine cutting-edge technology, quality, and care to transform lives every day.We're now looking for a Senior Quality Assurance Specialist to join our high-performing Operations team in Sydney. This role...

  • Project Director

    2 weeks ago

    Sydney, New South Wales, Australia Dowse Projects Full time $120,000 - $180,000 per year

    Join Dowse Projects as a Project Director – Lead Major Projects in New South WalesDowse Projects is a dynamic, independent project management consultancy delivering exceptional outcomes across residential, industrial, commercial, hotel, aged care, education, and federal government sectors. Our culture thrives on innovation, rigorous collaboration, and...

  • Director of Design And Development

    1 week ago

    Sydney, New South Wales, Australia TSHR Full time $104,000 - $130,878 per year

    Design & Development Director | Apparel & Fashion | SydneyAre you a dynamic leader with a passion for fashion, product innovation, and client relationship management? We're looking for aDesign and Development Directorto drive excellence across all aspects of design, development, and production with a competitive base salary + bonus structureAbout the Role:In...

  • Director - Assurance and Risk

    1 week ago

    Sydney, New South Wales, Australia Aon Corporation Full time $120,000 - $180,000 per year

    Director – Assurance and RiskLooking for a senior role with purpose and impact? This position is based in Sydney, with the freedom to work both virtually and from our office – a unique opportunity to drive assurance and risk excellence across Australia and PNGAon is in the business of better decisionsAt Aon, we build decisions for the better to protect...

  • Director, Quality Assurance APAC

    1 day ago

    Sydney, New South Wales, Australia Hologic Full time $120,000 - $180,000 per year

    DescriptionMarket leading developer & manufacturer of medical devices for Women's Health  Newly created role with an innovative and growing organisationAustralia or Singapore based with role scope across APACAre you looking for a place where the work you do is directly connected to positively impacting lives around the world? Are you searching for an...

  • State Director Project Delivery

    1 day ago

    Sydney, New South Wales, Australia BGIS Full time $120,000 - $250,000 per year

    State Director - Project DeliveryLocation: Sydney, NSWEmployment Type: Full-Time PermanentDivision: National ProjectsThis is a senior leadership opportunity to own the state's P&L, expand service offerings, and strengthen client relationships while guiding complex construction and fitout projects across NSW.About the RoleAs the State Director - Project...

  • Project Engineer

    1 week ago

    Sydney, New South Wales, Australia Versatile Group Full time $80,000 - $120,000 per year

    Are you an experienced Project Engineer looking to deliver exceptional engineering projects? We are seeking a driven and detail-oriented professional to join our dynamic team. In this role, you will play a key part in ensuring projects are executed with precision, quality, and within specified timeframes, all while maintaining compliance with Australian...