QA Manager – Pharmaceutical Manufacturing

Chester Hill/Regents Park, Western Sydney NSW

Full-Time Permanent Position

Pharmaceutical / Complementary Medicines Manufacturing

About the Opportunity

iHarbour Consulting is partnering with an established Australian pharmaceutical and complementary medicines manufacturer to recruit an experienced QA Manager for its manufacturing operation in Western Sydney.

This is a key leadership position responsible for maintaining and strengthening the site's Quality Management System, ensuring ongoing compliance with TGA and GMP requirements, and supporting quality across manufacturing, testing, packaging and product release activities.

The successful candidate will work closely with senior management, production, QC, technical and regulatory teams to maintain a strong quality culture across the business.

Key Responsibilities

As QA Manager, your responsibilities will include:

- Lead and maintain the site's Quality Management System (QMS)

- Ensure ongoing compliance with TGA, PIC/S GMP and applicable regulatory requirements

- Manage deviations, investigations, CAPA and change control processes

- Oversee document control, SOPs, specifications and quality records

- Coordinate and support internal, external, supplier and regulatory audits

- Lead preparations for TGA and other regulatory inspections

- Review manufacturing and quality documentation to ensure GMP compliance

- Support batch documentation review and product release processes

- Oversee validation and qualification activities across equipment, processes, cleaning and facilities

- Manage quality risk assessments and continuous improvement initiatives

- Monitor quality trends, KPIs and recurring compliance issues

- Work closely with Production and QC to investigate quality and manufacturing issues

- Support supplier qualification and ongoing supplier quality management

- Ensure appropriate GMP training and quality awareness across the site

- Provide leadership, coaching and direction to members of the Quality Assurance team

- Promote a strong culture of compliance,