Senior QA/RA Manager

About Us

Care Essentials PharmAust is a Perth-based pharmaceutical and healthcare manufacturing business operating in a GMP-regulated environment. We manufacture a range of pharmaceutical and related products for Australian customers and are entering an important stage of growth, with a focus on strengthening our quality systems, manufacturing capability, and operational support.

This is an opportunity for an experienced senior quality assurance professional to take charge of the QA/RA team in a hands-on manufacturing environment, where your experience, judgment, and leadership will make a genuine impact.

The Opportunity

We are seeking an experienced Senior QA/RA Manager to lead and support the QA function across our GMP manufacturing site.

This is a senior, hands-on role suited to someone with strong GMP knowledge, practical manufacturing experience, and the ability to work with all stakeholders both internal and external, to get the job done.

The successful candidate will play a critical role in maintaining and improving the site’s quality systems, managing GMP documentation, preparing for audits, supporting product and process activities, and ensuring products are manufactured in accordance with regulatory, customer, and quality requirements.

Key Responsibilities

Reporting to senior management, your responsibilities will include:

• Maintain the site quality management system.

• Lead customer, certification, and regulatory audits.

• Manage GMP documentation, SOPs, forms, registers, and controlled documents.

• Manage deviations, CAPAs, change controls, complaints, and investigations.

• Ensure specifications, manufacturing instructions, packaging records, and quality documentation are up to date.

• Conduct validation activities including process validation, cleaning validation, and equipment qualification documentation.

• Manage supplier qualification and raw material approval processes.

• Assisting with quality agreements, technical documentation, and customer quality requests.

• Drive continuous improvement within the QA function and broader site operations.

About You

You will be an experienced QA professional with a strong understanding of GMP manufacturing requirements and the ability to work in a practical, hands-on environment.

The ideal candidate will have:

• Previous experience as a QA manager in a GMP certified pharmaceutical company.

• Strong GMP experience within pharmaceutical, therapeutic goods, complementary medicines, or related manufacturing.

• Experience in developing technical documents, SOPs and other quality documents for new products.

• Experience with product transfers, validation, supplier qualification, or regulatory inspections would be highly regarded.

• Experience with batch record review, deviations, CAPAs, and change control.

• Experience and ability to lead and manage a team.

• Experience leading audits and customer quality requirements.

• Strong communication skills and the ability to work across QA, QC, production, and management.

• Confidence to make quality decisions and escalate risks when required.

What We Are Looking For

• Bachelor's degree in science.

• Over 5 year's experience as a QA Manager.

• Experience in a reputed GMP certified pharmaceutical company.

A competitive salary package will be offered based on experience and suitability for the role.

If you are an experienced QA professional looking for a hands-on leadership role within a GMP manufacturing environment, we would like to hear from you.

Please apply with your resume and a short cover letter outlining your relevant QA, GMP, and manufacturing experience.