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Quality Assurance Manager

GPN VACCINES

Job Description

Position Summary 

GPN Vaccines is seeking a part-time Quality Assurance Manager to help develop, implement and manage a Quality Management System (QMS). The Quality Assurance Manager will work closely with GPN Vaccines’ Executive and R&D teams across a range of areas including manufacturing, preclinical and clinical studies, regulatory filings and general operations. This role has a focus on internal activities, with some contribution towards contractor management. Ideally the Quality Assurance Manager will be based in Adelaide, however we will consider interstate candidates who are able to travel to Adelaide on a monthly basis and work remotely. 

 

Key Responsibilities 

  • Work with the GPN Vaccines R&D team to develop, implement and manage a QMS including drafting SOPs and test methods
  • Work with the Director of Regulatory and Quality to oversee audits of external contractors, clinical research sites, suppliers and manufacturing partners
  • Assist with the review of documentation from external contractors including manufacture batch documentation and reports
  • Support the management of any quality-related issues with external contractors/clinical sites/shipments

 

Essential Selection Criteria 

  • Science degree or equivalent
  • Quality assurance experience in the pharmaceutical and/or biotechnology industry
  • Experience within GxP; especially GMP and/or good research practice requirements
  • Excellent verbal and written English language skills, attention to detail and time management skills

 

Desirable Selection Criteria 

  • Experience with vaccines and/or biologics is a significant advantage
  • Experience working in a small biotechnology company
  • Experience in supporting regulatory submissions, especially to the FDA, TGA and EMA

 

Other Information 

  • Occasional availability outside normal working hours may be required
  • To be eligible for this position you must be an Australian citizen or permanent resident
  • You may be required to consent to a police check
  • This position will have no direct reports

 

How to Apply

If this opportunity sounds like you and you are ready to take on your next challenge, then please submit a cover letter addressing the selection criteria and resume via Seek.

 

About GPN Vaccines 

GPN Vaccines is a public (unlisted) biotechnology company developing a vaccine against Streptococcus pneumoniae, which is responsible for causing life-threatening pneumonia, bacteraemia and meningitis, as well as otitis media (middle ear infections). Each year it causes 1-2 million deaths worldwide, killing more children than AIDS, malaria and tuberculosis combined. There are now 100 different serotypes of S. pneumoniae and the best vaccine currently on the market only protects against 13 of them. Gamma-PN, GPN Vaccines’ new S. pneumoniae vaccine, is being developed to protect children and adults against all S. pneumoniae strains, regardless of strain serotype. For more information, please visit www.gpnvaccines.com.