Proclinical
is seeking a
Quality Systems Specialist
to join our client, a pioneering biologics manufacturer establishing
Australia's first facility dedicated to viral vector production
for advanced therapies. Following the successful launch of their state-of-the-art site, the business is expanding its Quality function to strengthen
GMP compliance, regulatory readiness, and continuous improvement
initiatives.
This role presents an opportunity to help shape the foundation of a
world-class Quality System
supporting the future of advanced therapies in Australia.
Role Overview
Reporting to the
Quality Systems Manager
, the
Quality Systems Specialist
will support, maintain, and continuously improve the site's Quality Management System (QMS) in accordance with
cGMP, TGA, and international regulatory requirements
.
You'll drive process optimisation, oversee compliance documentation, lead internal audits, and champion a proactive quality culture across the organisation.
Duration:
Permanent, full-time
Start Date:
ASAP
Hours:
Standard Monday–Friday business hours
Capacity:
On-site
Location:
Sydney, NSW
Work Rights:
Full unrestricted working rights (Citizen or Permanent Resident)
Role Responsibilities
* Support and enhance the site
Quality Management System
, ensuring alignment with GMP and global quality standards.
* Collaborate with the
Quality Systems Manager
to achieve quality objectives and improvement targets.
* Lead and manage
change controls, deviations, CAPAs, risk assessments, audits, complaints, recalls, staff training, supplier management
and
quality agreements
.
* Author, review, and maintain
SOPs
,
quality procedures
,
work instructions
and
eQMS
in compliance with GMP requirements.
* Conduct and support
internal audits
to assess compliance with
cGMP
and
TGA
regulatory compliance frameworks.
* Facilitate
management reviews
and provide trend analysis and metrics to site leadership.
* Ensure
inspection readiness
and support third-party, client, and regulatory audits.
* Drive
data integrity and continuous improvement programs
to strengthen quality operations.
* Partner cross-functionally with Operations, QC, Engineering, and Process Development teams to ensure quality standards are upheld.
* Promote a
culture of quality and compliance
, providing mentoring, training, and guidance across departments.
Skills and Experience
* Bachelor's degree in
Science, Engineering, or a related discipline
.
* 3–5+ years' experience
in Quality Systems or Quality Assurance within a
GMP-regulated
pharmaceutical, biotechnology, or CDMO environment.
* Strong working knowledge of
GMP / cGMP, TGA, and international regulatory frameworks
.
* Proven experience in
managing quality records
(deviations, CAPAs, change control, complaints, audits, etc.).
* Demonstrated ability to identify and lead
process improvement
initiatives.
* Strong
communication, documentation, and organisational skills
.
* Excellent attention to detail, decision-making, and problem-solving capabilities.
* Proactive and adaptable mindset, capable of thriving in a
fast-evolving manufacturing environment
.
* Commitment to fostering a culture of
continuous improvement, integrity, and collaboration
.
How to Apply
If this opportunity aligns with your experience and career goals, please click
'Apply Now'
to submit your application.
For a confidential discussion or to learn more about this role, please contact
Pamela Phoumavong
at
or call
.
About Proclinical
Proclinical is a specialist life sciences recruitment agency, providing job opportunities within leading
pharmaceutical, biotechnology, biopharmaceutical, and medical device
organisations worldwide.
Proclinical Staffing is an
equal opportunity employer
.