Job Title

BiomeCentric is Australias leading Contract Development and Manufacturing Organisation (CDMO) specialising in the microbiome. We partner with innovative health, wellness, and beauty brands to develop and manufacture nextgeneration products grounded in worldclass science. From advanced laboratory testing through to fullscale TGAlicensed cGMP manufacturing, we operate at the forefront of microbiome innovation, fermentation, and biotechnology. This is an opportunity to join a fastgrowing, scienceled organisation shaping the future of microbiome health and beauty. About the Role We are seeking an experienced Quality Manager to lead Quality across our TGAlicensed 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 handson 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, innovationdriven biotech company Collaborate with leading Australian and global brands Be part of a valuesdriven 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 highgrowth, TGAlicensed manufacturing environment, wed 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? #J-18808-Ljbffr