Full-time | Site Leadership Role.
- Lead the quality function at a highly regulated sterilisation facility.
- Drive compliance, performance and continuous improvement.
- Play a pivotal role in site leadership and business growth.
About Us
Steritech is the leading and trusted contract sterilisation and decontamination processor in the Asia-Pacific region, and one of the largest worldwide. We are a customer and employee focused business that provides clients with unique opportunities to open their business to new markets through innovative, technically advanced solutions.
Position Overview
This is a senior site leadership position reporting to the Site General Manager, with a dotted line to the Group Manager – Quality & Regulatory.
As Site Quality Manager, you are accountable for the overall Quality Management System (QMS) at our Merrifield facility. You will lead all quality, compliance and regulatory activities to ensure our services consistently meet GMP, ISO, TGA, APVMA and customer requirements.
What You’ll Be Doing:
- This role is both strategic and operational. You will:
- Lead and continuously improve the site QMS in alignment with business and regulatory objectives
- Lead, coach and develop the site QA/QC team
- Certify and release processed customer loads
- Ensure compliance with GMP and Good Radiation Practice
- Lead internal, external and regulatory audits and inspections
- Drive resolution of non-conformances, customer complaints and CAPA activities
- Oversee calibration programs, process validations and re-commissioning activities
- Provide technical quality guidance to Operations and Maintenance teams
- Manage critical supplier and contractor qualification processes
- Embed a culture of accountability, continuous improvement and regulatory excellence
You will be a key voice in site decision-making and a trusted partner to operations, maintenance and commercial stakeholders.
Key Requirements
About You
You are an experienced quality leader from a highly regulated manufacturing environment who understands both compliance depth and operational realities.
You bring:
- Tertiary qualifications in Science, Engineering or related discipline
- 5–10+ years’ experience in pharmaceutical, medical device or similarly regulated manufacturing
- Strong working knowledge of GMP (PIC/S or equivalent), ISO 9001 and/or ISO 13485
- Experience with TGA audits and/or other regulatory body inspections
- Demonstrated capability in validation, qualification and calibration oversight
- Strong understanding of CAPA, root cause analysis, SPC and quality improvement methodologies
- Proven leadership experience managing and developing quality teams
- Confidence engaging with regulators, customers and senior stakeholders
- Sound judgement and decision-making capability in high-accountability environments
Experience in sterilisation or irradiation processing, and/or medical-grade cleanroom operations will be highly regarded.
Application Requirements
- Steritech ONLY accepts applications from all people with the right to live and work in Australia.
- Please include a covering letter addressed to the Hiring Manager.
- Preferred candidates will need to provide professional referees to provide working references.
- Successful candidates will be required to undergo a Pre-employment Medical check and National Police check.
Why Join Us?
- Genuine site-level ownership of the quality function
- High regulatory exposure and technical complexity
- Strong national quality framework support
- Opportunity to influence culture, systems and performance
- A leadership role within a growing, industry-leading organisation
Diversity Equality and Inclusion Declaration
Steritech is dedicated to building a diverse, inclusive and authentic workplace. We are committed to a culture of diversity and inclusion that embraces and celebrates the differences and similarities within our people.
Steritech welcomes and encourages applicants from all backgrounds, and all suitable candidates will be considered regardless of age, ability, race, gender expression, sex, cultural background, spiritual beliefs or lived experience.
