Head of Quality

• $180,000 to $220,000 plus super
• Lead Quality at a brand-new, licensed manufacturing facility
• Join 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 Responsibilities

Leadership & Culture

• Provide 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 & Compliance

• Ensure 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 & Systems

• Ensure 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 Improvement

• Partner 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 & Experience

Must 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 validation
• Proactively 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 Exergy

Exergy 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.*