About the Company We are partnering with a global provider of specialised laboratory and clinical research services supporting pharmaceutical and biotech sponsors worldwide. With strong expertise in biomarker, histology and translational science, the organisation operates within a highly regulated environment and is recognised for its quality, compliance and scientific rigor. Due to continued growth, they are seeking a Clinical Quality Assurance Officer to strengthen their QA function.
About the Role
Reporting into the Director of Quality, you will provide GCP oversight across clinical trials and associated laboratory services, ensuring compliance with ICH-GCP, global regulatory requirements and internal quality systems.
Key responsibilities include: - Conducting and supporting internal and external GCP audits (sites and vendors)
- Reviewing TMF and clinical study documentation
- Providing laboratory quality oversight within a clinical trial setting
- Managing deviations, CAPAs and quality events
- Supporting SOP development and inspection readiness
- Delivering GCP guidance and training across stakeholders
This role sits at the intersection of clinical operations and laboratory science, offering broad exposure across study and vendor oversight.
About You You are a detail-oriented QA professional with experience in regulated clinical research environments.
You will bring:
- Bachelor’s degree in Life Sciences or related field
- 3–5 years’ Clinical QA experience within pharma, biotech or ideally a CRO
- Strong working knowledge of ICH-GCP
- Experience conducting or supporting GCP audits
- Hands-on laboratory experience (e.g. clinical lab, biomarker, histology, molecular diagnostics)
- Experience managing CAPAs, deviations and quality systems
- Strong documentation review and stakeholder engagement skills
- CRO experience is highly desirable.
Benefits - Competitive salary and benefits
- Hybrid working model
- Exposure to innovative global clinical programs
- Clear career progression
- Collaborative, quality-driven culture
If you are a Clinical QA professional with GCP expertise and laboratory experience looking to take the next step in your career, please
APPLY NOW.
For a confidential discussion, please contact Ruby at KE Select on
ruby@keselect.com.
About KE Select KE Select is a specialist scientific and medical recruitment partner supporting the life sciences, clinical research, diagnostics, biotechnology and healthcare sectors across Australia, New Zealand and the Asia-Pacific region. We connect high-calibre professionals with leading organisations, ensuring strong technical alignment and long-term career fit.
All applications and discussions are handled with strict confidence.
