Lead quality, microbiology and regulatory compliance in a complex manufacturing environment
Pact Contract Manufacturing is looking for an experienced Quality Assurance & Microbiology Manager to join our manufacturing operation in Hornsby.
This is a hands-on quality leadership role with responsibility for ensuring products are fit for purpose and meet regulatory, customer and internal quality requirements. You’ll oversee our Quality Management System and onsite microbiological testing activities while leading a technical team of QA/QC Technicians and Microbiologists.
About the role
Reporting to the NSW Quality Manager, you’ll play a key role in embedding a strong quality and continuous improvement culture across the site, partnering closely with Production, Manufacturing, Purchasing, NPD and Customer Service.
You will:
- Lead and continuously improve the site Quality Management System (QMS).
- Drive GMP compliance across the manufacturing operation and laboratory.
- Maintain compliance with relevant TGA, ISO 22716, APVMA and BRC requirements.
- Manage the QC testing laboratory and onsite microbiological testing activities.
- Lead environmental monitoring and cleaning validation programs.
- Manage investigations, deviations, out-of-specification results and CAPA.
- Review and approve testing data and ensure accurate quality records.
- Lead and coordinate site audits and product recalls.
- Partner with suppliers, customers, auditors, regulatory authorities and external laboratories.
- Maintain key site certifications and licences, including TGA-GMP, ISO 22716, BRC, APVMA, ACO, RSPO and EPA requirements.
- Participate in validation of manufacturing systems and processes.
- Prepare and authorise Product Quality Reviews (PQRs) where required.
- Lead, coach and develop QA/QC and microbiology team members and build quality capability across the broader site.
About you
You’ll bring strong technical quality expertise combined with the confidence to influence stakeholders and drive high standards across a manufacturing environment.
Ideally, you will have:
- A Bachelor's degree in Pharmacy, with Pharmaceutics and Microbiology majors specified in the position description.
- Quality Management Systems experience within a TGA-regulated manufacturing environment.
- Strong GMP knowledge and experience.
- Experience conducting and supporting quality audits.
- Knowledge of microbiological testing and laboratory quality systems.
- Strong investigation, problem-solving and continuous improvement capability.
- The ability to communicate effectively across technical, operational and leadership teams.
- Strong written communication and reporting skills.
Why join us?
This role offers the opportunity to take ownership of a critical quality function within a diverse manufacturing environment, combining quality assurance, microbiology, laboratory leadership, regulatory compliance and continuous improvement.
You’ll have the opportunity to work closely with manufacturing and technical teams and make a tangible impact on product quality, consumer safety and our ongoing commitment to manufacturing excellence.
If you're an experienced quality professional looking for your next leadership opportunity in regulated manufacturing, we'd love to hear from you.