About BiomeCentric

BiomeCentric Pty Ltd is a TGA-licensed Good Manufacturing Practice (GMP) contract manufacturer located on the Gold Coast. We specialise in the formulation and manufacture of health supplements, beauty products, and animal care goods — spanning capsules, powders, liquids, topicals, and skincare. Our facility operates under strict regulatory standards and services a growing portfolio of national and international clients.

As we continue to expand, we are seeking an experienced Quality Assurance Manager to lead and embed our quality systems, drive compliance culture, and ensure every product that leaves our facility meets the highest standards of safety, efficacy, and regulatory expectation.

The Role

Reporting to senior leadership, the Quality Assurance Manager is a critical appointment responsible for the full ownership of BiomeCentric's quality management system (QMS). You will be a hands-on leader who is equally comfortable on the production floor as you are authoring SOPs or presenting to the board.

This is a broad, high-impact role suited to a QA professional who thrives in a dynamic manufacturing environment and understands what it takes to maintain a TGA licence.

Key Responsibilities

Quality Management System

•         Own, maintain, and continuously improve the site QMS in accordance with TGA GMP (PIC/S) requirements

•         Author, review, and approve SOPs, work instructions, and quality agreements

•         Drive site-wide compliance culture through coaching, training, and floor presence

•         Lead management review meetings and quality governance reporting to leadership

Audits & Inspections

•         Plan and execute the internal audit schedule across all GMP-relevant departments

•         Act as the primary contact for TGA inspections, regulatory authority visits, and client GMP audits

•         Prepare audit readiness programmes and ensure all observations and findings are resolved to closure

•         Conduct supplier and contract organisation audits (qualification, periodic, for-cause)

•         Manage CAPA programmes arising from audits, deviations, complaints, and inspections

Validation & Qualification

•         Oversee equipment qualification (IQ/OQ/PQ) and process validation programmes

•         Manage and maintain the cleaning validation programme, including protocol authoring and review

•         Lead or support method validations and stability programme design

•         Ensure change control, validation master planning, and re-validation triggers are managed effectively

Batch Release & Documentation

•         Review and approve Batch Manufacturing Records (BMRs) and release documentation

•         Manage deviation management, OOS/OOT investigations, and formal risk assessments

•         Oversee the complaints handling process, including trending and regulatory reporting obligations

•         Ensure document control systems are always maintained and audit-ready

Team Leadership

•         Lead, mentor, and develop the QA team (QA Officers, QA Specialists)

•         Set KPIs, conduct performance reviews, and manage workload allocation across quality functions

•         Partner with Production, NPD, and Warehouse teams to embed quality at source

About You

You are a seasoned QA professional with a deep understanding of GMP manufacturing and regulatory compliance. You lead by example, communicate clearly across all levels of the business, and bring structure and rigour without bureaucracy.

Essential Requirements

•         Minimum 5 years' experience in a Quality Assurance role within pharmaceutical, nutraceutical, or regulated manufacturing

•         Demonstrated experience managing TGA inspections and/or PIC/S GMP audits

•         Proven track record leading validation programmes (cleaning, process, equipment qualification)

•         Thorough working knowledge of PIC/S GMP guidelines and TGA Code of GMP

•         Experience authoring and managing SOPs, deviations, CAPAs, and quality risk assessments

•         Tertiary qualification in Science, Pharmacy, Chemistry, or a related discipline

•         Strong leadership and people management skills with experience developing QA teams

Highly Regarded

•         Experience in complementary medicine (CMVP), listed medicines, or TGA-registered products

•         Familiarity with contract manufacturing environments and multi-client QMS management

•         Exposure to skincare/topicals, liquids, or encapsulation formats

•         Experience with electronic QMS or batch record management systems

What We Offer

•         Competitive salary package negotiable on experience

•         Genuine opportunity to shape and own the QA function in a growing GMP facility

•         A collaborative, hands-on team environment with direct access to leadership

•         Stable, permanent full-time role in a well-established and expanding business

•         Gold Coast location — work where others holiday