Quality Consultant

The Opportunity

The Consultant manages client projects, working closely with other team members to deliver a superior client experience, optimise project outcomes, and contribute to the culture and capabilities of the team.

This permanent, full-time position reports to the Manager and works within the Regulatory, Quality & Compliance team to deliver a range of regulatory, quality and compliance services within Australia, New Zealand and Japan and Asia Pacific (JAPAC) region. 

The role acts as a Project Team Leader, participates in assigned projects and support project teams as required.

The role contributes to the BU’s business growth efforts by proactively identifying business development opportunities and working with existing and potential clients in the healthcare sector to anticipate and understand their business needs and identify areas or activities with which CE can assist. 

Key responsibilities include:

Fostering relationships and collaborating with other business units to support cross-collaboration within the business, drive innovation, create efficiencies, and expand service offerings across the business. 

Providing high-quality work that contributes to client satisfaction and loyalty, leading to optimisation of repeat business and expansion of service provision across the Regulatory, Quality & Compliance service offering. 

Provide quality and compliance services to clients to support supply of registered or listed pharmaceuticals, biologicals and medical devices. This includes among other activities, reviewing and maintaining Quality Management Systems (QMS) and overseeing the release for distribution to ensure products meet regulatory standards.

Lead and manage projects of varying sizes, coordinating both small and large project teams to support the needs of multiple clients, ensuring projects are completed on time and within scope.

Provide expert advice on quality-related matters, offering both general guidance and strategic recommendations to clients to help them navigate complex regulatory requirements and improve their overall quality practices.

Manage GMP clearance applications for submission to the TGA, including preparing and reviewing documentation, ensuring compliance with TGA standards, and coordinating with internal teams and clients to facilitate approval.  

The Team

Our highly experienced Regulatory, Quality and Compliance team has deep expertise in maintaining high-quality standards across the product lifecycle. We support our clients by developing effective quality management strategies, helping them navigate complex quality challenges during development, production, and ongoing product supply. With a proven track record, we successfully manage over 160 projects annually, ensuring top-quality outcomes and adherence to industry standards.

When you become part of our team, you’ll immediately feel welcomed, supported, and appreciated. Our unique and challenging consulting environment fosters a strong sense of collaboration, and it is second to none, even when working remotely. At CE, we:

Thrive on providing creative solutions to complex problems.

Love being exposed to diverse projects.

Feel comfortable with ambiguity and see it as an opportunity to generate insights.

Enjoy hands-on work as well as being the subject matter expert.

Feel inspired to deliver work that makes a difference in people’s lives through health.

Work flexibly and adapt quickly to changing priorities.

“Managing such a wonderful team at CE is what I enjoy the most – our diverse range of projects and clients allows each team member to both utilise and develop their expertise and I am so proud of the excellent service we are able to provide” – Colleen, Senior Manager, Regulatory, Quality and Compliance

About you

This role is a fantastic opportunity for an experienced quality assurance professional with expertise in the Australian, New Zealand, and/or JAPAC regulatory landscapes. You bring a proven track record in quality roles and have a passion for both learning and sharing your knowledge of the pharmaceutical or healthcare industry. Strong project management skills and exceptional communication abilities are key to succeeding in this role.

Our head office is based in the heart of Melbourne’s CBD, where we operate from a collaborative workspace. We operate under a hybrid model and offer flexibility in accordance with our company’s flexible work policy.

Desired qualifications and experience

Have completed studies in pharmaceutical sciences or related scientific fields.

Proven record of experience in quality assurance, preferably in both consulting and commercial environments.

Good knowledge of legislation, regulations, guidelines and working procedures within the JAPAC region.

Experience in auditing GMP (Good Manufacturing Practice) and/or GCP (Good Clinical Practice) processes in external audits, assessing compliance with manufacturing and clinical trial standards.

Experience in review, critical evaluation and presentation of technical data.

Proven problem-solving and project management skills. 

Post-graduate qualifications in a relevant discipline are preferable.