* Join a supportive team with strong growth and career opportunities
* Your voice will matter Shape the future and make a real impact every day
* Permanent role in a collaborative team with modern, well-equipped facilities
ABOUT OUR CLIENT
Join a fast-growing Australian manufacturing company committed to innovation, quality, and health
We are seeking a Quality Manager to join a dynamic, well-supported business based in Melbourne's south-east. With a clear vision for significant growth over the next five years, the company boasts strong leadership, modern facilities, and a TGA-licensed operation. They're on a bold mission to disrupt the complementary medicines market with innovative, high-quality alternatives.
The company's TGA-licensed manufacturing and warehouse facilities form the cornerstone of their growth strategy. To support this journey, they're looking for a proactive and experienced hands-on Quality Manager to join their collaborative team—driving excellence in compliance, product safety, and operational performance.
The Opportunity – Permanent Full-time Role
Reporting directly to the Chief Operating Officer, this is a pivotal role in ensuring all products meet the highest regulatory standards. As the Quality Manager, you will lead all aspects of Quality Assurance and Quality Control, oversee regulatory compliance and validation activities, and play a key role in maintaining their TGA Manufacturing Licence. You'll also help shape and support their growth trajectory with your insight and leadership.
This is a rare opportunity to build something from the ground up in a progressive business with significant investment behind it. Your voice will be heard—and your contribution will directly shape the future of the company.
key Responsibilities
* Lead the Quality function, driving GMP compliance and continuous improvement across the site.
* Act as the Authorised Person under the TGA Manufacturing Licence for release for supply.
* Oversee audits (TGA, FDA, third-party), documentation control, CAPA, and validation programs.
* Collaborate cross-functionally with Production, R&D, and Regulatory teams to resolve quality issues and ensure compliance, supporting manufacturing scale-up and international market expansion.
* Mentor, train and develop a small quality team to support operational excellence.
Requirements
* Bachelor's degree in Chemistry, Life Sciences, or related field.
* ·At least 5 years of management or leadership experience in pharmaceutical, nutraceutical, or complementary medicine environments, primarily in manufacturing, quality assurance, or quality control.
* Proven track record leading internal (quality, safety, departmental) and external audits (TGA, FDA), including successful management of TGA inspections and validation programs.
* Extensive expertise in method and equipment validation, including design, execution, monitoring, documentation review, and driving process improvements.
* Skilled in managing GMP compliance, maintaining up-to-date GMP evidence, and ensuring timely TGA Pre-Clearance submissions to avoid product registration delays.
* Strong ability to identify and anticipate regulatory risks and obstacles throughout the product lifecycle, contributing to multi-country regulatory strategies and collaborating closely with company directors on solutions.
* Demonstrated technical knowledge of qualification, validation, risk analysis, and regulatory documentation approval within a regulated environment.
* Excellent leadership, stakeholder engagement, decision-making, time management, and problem-solving skills.
* Commitment to workplace health and safety, ensuring compliance with company policies, procedures, and statutory obligations.
Why Apply?
* Play a lead role in a business with global potential and committed owners.
* Help bring innovative, ethical health products to market.
* Enjoy a collaborative and supportive culture with real room to grow.
* Long-term career development opportunities
* Be part of a passionate team building something meaningful from the ground up.
Please note: Candidates must have full Australian working rights and relevant GMP experience to be considered.
Ready to Make Your Mark?
If you're looking for a hands-on leadership role where you can make a lasting impact, please call Helen on ************ or Jo on ************ for a confidential discussion.
APPLICATIONS
To be considered for this role please apply at your earliest convenience by using the 'Apply' button below. Please include your updated resume with a cover letter in Word Format to CS Executive Group.
THANK YOU
Given we appreciate the effort it requires to express an interest in response to a job advert, we would like to thank you in advance for taking the time to apply for this role. Unfortunately, due to the large volume of applications we receive daily, we typically only make contact with individuals whom we consider to have suitable qualifications and experience to be assessed further for shortlisting.
Nevertheless, all resumes submitted to CS Executive Group are retained on our database—you might therefore be contacted by us for suitable roles arising in the future.
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