Quality Systems Specialist

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
.