Associate Director Quality Assurance
4 days ago
Associate Director, Quality
Location:
Boronia, VIC |
Employment Type:
Full-time, On-site
Lead quality excellence in a complex and evolving pharmaceutical landscape.
Founded in 1975, IDT Australia is a publicly listed pharmaceutical manufacturing company based in Boronia, Victoria. We specialise in three strategic pillars:
- API synthesis, scale-up, and cGMP manufacture
of high-potency molecules - Specialty Orals
for neurological disorders - Advanced Technology
for complex injectable drug development, including RNA and Antibody Drug Conjugates
We are seeking a seasoned and adaptable Associate Director, Quality to join our team. This leadership role acts as the 2IC to the Director of Quality (QA and QC), serving as their delegate and authorised person in their absence.
You'll lead key quality functions and contribute to strategic initiatives that ensure compliance, drive continuous improvement, and support innovation across our manufacturing operations. This role is ideal for someone with broad experience across
quality systems, validation, microbiology, compliance, and team leadership
—even if not all areas are covered.
Key Responsibilities
- Oversight of Total Quality Management Systems and GMP compliance
- Lead validation activities for facilities, equipment, cleaning, sterilisation, and aseptic processes
- Manage quality risk assessments, deviations, CAPAs, and continuous improvement initiatives
- Support and respond to TGA, FDA, and customer audits
- Drive supplier and vendor assurance programs
- Lead documentation systems and change implementation projects
- Mentor and develop quality teams, fostering capability and resilience through change
- Oversee microbiological testing, environmental monitoring, and cleanroom validation
- Manage process water systems, pest control, and product compliance (e.g. NICNAS, SUSMP)
- Handle customer complaints, investigations, and trending for improvement
What You'll Bring
- Minimum requirement is bachelor's degree in Science, Engineering or related medical / scientific field. Post graduate qualifications – MBA or MSc will be highly regarded in addition to leadership development and training.
- 10+ years professional industry experience and demonstrated leadership experience.
- Pharmaceutical industry experience through the molecule value stream for development, scale up, manufacture, supply chain and commercial.
- Strong foundation in Quality Assurance, Validation, and Compliance
- Experience with GMP, GLP, and regulatory audit environments
- Leadership in managing cross-functional teams and driving change
- Familiarity with microbiology, contamination control, and cleanroom operations
- Excellent communication, documentation, and training skills
Open to candidates located in Australia only, with full working rights.
This is a unique opportunity to step into a senior leadership role and help shape the future of quality at IDT Australia. If you bring a broad skillset and a passion for quality excellence, we'd love to hear from you.
To express your interest
, please email your resume to
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