Quality Manager
cGMP | TGA-Licensed Manufacturing | Microbiome Biotech
đź“Ť Gold Coast, QLD
About BiomeCentric
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:
o Design Qualification (DQ)
o Installation Qualification (IQ)
o Operational Qualification (OQ)
o 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
Leadership & Collaboration
* 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
Essential
* 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
Desirable
* Experience in supplements, therapeutics, cosmetics, or biotech manufacturing
* Experience with equipment, process, cleaning, and facility validation
* ERP / MRP systems experience
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.