Quality Manager - Clinical Trials

Nucleus Network; City of Melbourne; On-site; AUD 120,000 - 165,000; Full time

Benefits offered by this job

Fitness Passport

Reward Hub discounts

Wellbeing initiatives

Recognition programs

EAP support

Job summary

Nucleus Network is recruiting a Quality Manager to provide on-the-floor quality guidance and strengthen the Quality System across the site. You will support realisation activities, uphold data integrity, and drive continuous improvement in processes and documentation.

Join a growing global clinical research organisation with opportunities to develop leadership capabilities, manage CAPA, audits and training, and contribute to compliant, high-quality trials.

Qualifications

• Bachelor of Science in a relevant quality or technical discipline.
• 2–5 years’ experience in quality within clinical, medical or pharmaceutical industry.
• Practical knowledge of GXP quality systems and ISO 9000.
• People management or leadership experience.
• Demonstrated ability to implement improvements and increase process efficiency.
• Experience with training documentation for learning and development.
• Good knowledge of GCP and/or GMP.
• Experience with QA documentation and Good Documentation Practices.
• Experience in a TGA and/or FDA-regulated environment.

Responsibilities

• Provide on-the-floor quality support to operational areas, promoting data integrity.
• Manage site Quality Events and CAPA with rapid-response when issues arise.
• Perform label and batch quality release activities.
• Support change control and risk management activities.
• Improve documentation quality control by identifying trends and partnering with teams.
• Conduct internal audits of functions, processes and studies.
• Oversee equipment maintenance, calibration and validation.
• Contribute to creation and improvement of clinical study templates.
• Participate in site initiation visits, protocol reviews and safety reviews.
• Develop training materials and deliver site-based training as required.

Skills

Quality management

CAPA

GxP awareness

Documentation

Audits

Change control

Risk management

Training delivery

Education

Bachelor of Science in quality or technical discipline

Tools

GXP systems

ISO 9000

Job description

Join Nucleus Network as a Quality Manager and help advance medicine while building a rewarding career in clinical research.

As the world's leading Phase 1 clinical trials specialist, with facilities across Australia, the USA, and the UK, we partner with global pharmaceutical and biotechnology companies to help bring new medicines to patients.

Why Join Nucleus Network?

Work with purpose and contribute to research that improves lives worldwide.

Ask better questions and find smarter ways of working in an environment that values innovation and continuous improvement.

Start here, go further with exposure to the full clinical trial lifecycle and opportunities to develop your career.

Be visible at scale in a global organisation where your contribution is recognised.

Grow in a growing place, with expanding operations creating new opportunities across the business.

Join a culture of curiosity where learning, collaboration and new ideas are encouraged every day.

Access to benefits include Fitness Passport, Reward Hub discounts, wellbeing initiatives, recognition programs and EAP support.

About the role

The Quality Manager is a key member of Nucleus Network’s Quality team, providing operational quality support to functional teams and assisting in the management of the Nucleus Network Quality System.

In this role, you will support trial realisation activities across all departments by providing practical, on-the-floor quality guidance and strengthening the consistency, reliability and integrity of operational processes and data. Other duties may be required as the site continues to operationalise.

Working alongside collaborative and experienced operational teams, you will help deliver compliant clinical trials while driving continuous improvement across quality systems, documentation and site practices.

Build a long-term career with opportunities to broaden your quality expertise, influence site-wide improvements and develop your leadership capability.

Key responsibilities

• Provide on-the-floor quality support to operational functional areas, promoting consistency, reliability and data integrity.
• Manage/Review site Quality Events and corrective and preventive action (CAPA) processes, providing rapid-response support when issues are identified.
• Perform label and batch quality release activities.
• Support change control and risk management activities.
• Strengthen documentation quality control practices by identifying trends and partnering with operational teams to improve processes and documentation integrity.
• Conduct internal audits of functions, processes and clinical studies.
• Oversee equipment maintenance, calibration and validation activities.
• Contribute to the creation, management and continuous improvement of clinical study templates.
• Participate in site initiation visits, clinical study protocol reviews and study safety reviews, as required.
• Develop training materials and deliver site-based training as required.

Requirements

• Bachelor of Science in a relevant quality or technical discipline.
• Two to five years’ experience in quality or a related field within the clinical, medical or pharmaceutical industry is desirable.
• Practical knowledge of and experience with GXP quality systems and ISO 9000.
• People management or functional-area leadership experience.
• Demonstrated ability to implement improvements and increase process efficiency.
• Experience supporting learning and development teams with training documentation.
• Good practical knowledge of global Good Clinical Practice (GCP) requirements and/or Good Manufacturing Practice (GMP).
• Experience with quality system documentation and Good Documentation Practices.
• Previous experience in a TGA and/or FDA-regulated pharmaceutical or life sciences environment.

All offers of employment are conditional upon:

• Right to work verification.
• Vaccination compliance, including Hepatitis B, Varicella, MMR and Pertussis, with serological testing for all participant-facing and sample-facing roles.

Nucleus Network is an equal opportunity employer. We value diverse backgrounds, inclusive teams and people who are driven by purpose, curiosity and care.

To learn more, visit Nucleus Network or follow us on LinkedIn Careers Page, Instagram and Facebook.