BiomeCentric is Australia's leading Contract Development and Manufacturing Organisation (CDMO) specialising in the microbiome.
We partner with innovative health, wellness, and beauty brands to develop and manufacture next-generation products grounded in world-class science.
From advanced laboratory testing through to full-scale TGA-licensed cGMP manufacturing, we operate at the forefront of microbiome innovation, fermentation, and biotechnology.
This is an opportunity to join a fast-growing, science-led organisation shaping the future of microbiome health and beauty.
About the Role
We are seeking an experienced Quality Manager to lead Quality across our TGA-licensed cGMP manufacturing facility.
This is a senior leadership role with Authorised Person (Release for Supply) responsibility, reporting directly to the CEO.
You will own the Pharmaceutical Quality System and play a critical role in regulatory compliance, validation, product release, and continuous improvement as the business scales.
Key Responsibilities
Quality & Compliance
Lead and maintain the Pharmaceutical Quality System (PQS)
Ensure compliance with TGA GMP, cGMP, GLP, HACCP, and cosmetic regulations
Act as primary quality representative during TGA inspections and audits
Own deviations, CAPAs, change control, and quality risk management
Approve SOPs, specifications, and controlled documents
Validation & Qualification
Own the validation lifecycle across facilities, equipment, utilities, processes, cleaning, and systems
Oversee and approve:
Design Qualification (DQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Approve Validation Master Plans, protocols, reports, and revalidation programs
Ensure validation status supports Release for Supply
Release for Supply
Act as Authorised Person for release or rejection of raw materials, bulk, and finished goods
Review batch records, QC results, stability status, validation status, and deviation closure
Ensure products meet all regulatory and quality requirements prior to release
Lead and develop the Quality team (including QC)
Deliver GMP and validation training across the site
Partner closely with Manufacturing, Engineering, Regulatory Affairs, and Supply Chain
Support customer timelines while maintaining regulatory excellence
About You
Degree in a scientific (or related) discipline
Minimum 5+ years' experience in Quality within a cGMP manufacturing environment
Eligible to act as an Authorised Person for Release for Supply (TGA GMP)
Strong hands-on experience with DQ, IQ, OQ, PQ and validation lifecycle management
Excellent knowledge of TGA GMP and regulated manufacturing environments
Experience in supplements, therapeutics, cosmetics, or biotech manufacturing
Experience with equipment, process, cleaning, and facility validation
Why Join BiomeCentric?
Work at the forefront of microbiome science and manufacturing
Senior leadership role with real influence and autonomy
Join a rapidly scaling, innovation-driven biotech company
Collaborate with leading Australian and global brands
Be part of a values-driven organisation that prioritises quality, integrity, and impact
How to Apply
If you are a senior Quality professional ready to play a key role in a high-growth, TGA-licensed manufacturing environment, we'd love to hear from you.
Apply now with your resume and cover letter outlining your experience and suitability for the role.
Unlock job insights
Your application will include the following questions:
Which of the following statements best describes your right to work in Australia?
How many years' experience do you have as a Quality Manager?
Have you worked in a role which requires a sound understanding of Good Manufacturing Practices (GMP)?
How many years' experience do you have in a quality assurance (QA) role?
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