Head of Quality

$180,000 to $220,000 plus superLead Quality at a brand-new, licensed manufacturing facilityJoin an innovative, scaling, Australian-owned business at a pivotal growth stage.Exergy is a TGA-licensed complementary medicines manufacturer producing tablets, capsules, powders, and liquid compounds. We are seeking an experienced and inspiring Head of Quality to join our senior leadership team.This is a rare opportunity to lead a critical function at the heart of a growing, innovative business — where compliance is a given, and collaboration drives results. If you are a proven Quality leader with pharmaceutical or complementary medicine experience, and you're looking to make an impact in a supportive and forward-looking organisation, we'd love to hear from you.In this pivotal leadership role, you will:Lead and develop the Quality function, building a culture of accountability, collaboration, and continuous improvement across the site.Ensure full compliance with TGA PIC/S GMP through oversight of QA, QC, Validation, batch release, Product Quality Reviews, deviations, CAPAs, and change controls.Drive inspection readiness and regulatory confidence by hosting TGA, sponsor, and customer audits, and ensuring timely, sustainable closure of findings.Strengthen external quality performance by managing supplier qualification, audits, quality agreements, and partnerships with sponsors and customers.Partner with senior leadership to set and deliver the site's Quality strategy, using metrics, continuous improvement, and risk-based decision making to support safe, effective, and compliant products.The ResponsibilitiesLeadership & CultureProvide clear direction and leadership to the Quality team, inspiring collaboration across Production, Engineering, Supply Chain, and R&D;Build a culture of shared accountability for quality across all departments, embedding a "right the first time" mindset;Act as a role model for integrity, transparency, and customer focus;Develop, mentor, and succession-plan quality professionals to grow capability within the organisation;Lead quality training programs across the site to ensure employees understand and comply with GMP and site procedures.Quality Assurance & ComplianceEnsure the site maintains compliance with TGA PIC/S GMP requirements and other relevant regulatory and sponsor requirements;Manage the Authorised Person for product release, ensuring batches meet regulatory and sponsor requirements;Maintain oversight of deviations, investigations, CAPAs, change controls, and complaints, ensuring effective root cause analysis, risk assessment, and timely closure;Oversee Product Quality Reviews (PQRs), ensuring timely completion, review of trends, and implementation of improvements;Oversee supplier qualification, raw material approval, quality agreements, and audits of suppliers, contractors, and external laboratories;Ensure validation and qualification activities (equipment, facilities, processes, cleaning, analytical methods, utilities, computer systems) are compliant and documented;Maintain inspection readiness; host and manage external audits and inspections (TGA, sponsors, customers) and ensure timely closure of deficiencies;Oversee complaint handling, product returns, and recall management, ensuring compliance with regulatory requirements and effective root cause analysis;Quality Control & SystemsEnsure QC testing, laboratory practices, and documentation meet GMP requirements and data integrity standards;Oversee integrity and accuracy of all laboratory data, including electronic systems (LIMS, audit trails, backups);Maintain and continuously improve the site's Quality Management System (QMS), document control, and record retention;Lead internal audit programs and ensure findings are effectively addressed;Oversee stability studies, trending, and reporting to support shelf life and retest interval justifications.Strategy & Continuous ImprovementPartner with the leadership team to set and deliver the site's Quality strategy in line with business objectives;Define and report key quality metrics (deviations, CAPA closure times, OOS rates, supplier performance, audit findings) to senior leadership, using data to drive improvement;Lead initiatives to simplify and strengthen quality systems, aligning with operational excellence and lean manufacturing principles;Monitor changes in regulatory and industry standards (PIC/S, ICH, ISO) and update site practices accordingly;Collaborate with management, internal departments and sponsors to ensure clear communication and alignment on product quality and production expectations;Qualifications & ExperienceMust haves:Tertiary qualifications in a relevant discipline (i.e., science, medicine, health, or life sciences);Minimum 10 years experience experience in GMP-regulated manufacturing (pharmaceuticals, complementary medicines, or food industries);Demonstrated success leading Quality teams (QA, QC, Validation) of 5+ employees in a TGA-licenses or similar regulated facility;In depth knowledge of cGMP and PIC/S and application in manufacturing environments;Solid understanding of regulatory requirements for therapeutic and non-therapeutic products including a strong working knowledge of Quality Risk Management and Compliance;Understanding of regulatory requirements for compounded medicines manufactured in a licensed TGA facility;Experience managing external parties (suppliers, contract manufacturers, laboratories) through qualification, audits, and quality agreements;Familiarity with electronic quality systems (e.g., LIMS, ERP, eQMS) and computerised system validationProactively ensure appropriate quality criteria are considered in decisions made by senior management;Track record of hosting regulatory and customer audits with successful outcomes;This is a permanent, full-time role and requires unrestricted and ongoing work rights in Australia;Nice to haves:Leadership experience in a TGA-licensed complementary medicines facility;Postgraduate qualifications (e.g., MSc, MBA, GxP quality certifications);Experience collaborating on pharmacovigilance processes with sponsors;Training in Lean/Six Sigma or operational excellence methodologies.About ExergyExergy is part of a larger group supporting Australia's complementary health sector across distribution, manufacturing, and service delivery. Our new Smeaton Grange facility is central to this long-term growth strategy. As Head of Quality, you'll play a defining role in setting standards, building capability, and shaping the future of Australian-made complementary medicines.This is an on-site role at our Smeaton Grange facility.*Please no recruiters and agencies. We are filling this role in-house.*