RA/QA Director
7 days ago
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
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