Quality Assurance Manager – Pharmaceutical Manufacturing
Location: Warriewood, NSW | Full-Time

Our client is a well-established pharmaceutical manufacturer based in Warriewood, offering a rare opportunity to lead quality operations in a GMP-compliant facility—without the city commute.

This role combines leadership, autonomy, and impact within a supportive and collaborative team. If you’re looking for a career-defining role in a growing company that values quality and compliance, this is an excellent next step.

Key Responsibilities:

Maintain, review, and update the Quality Management System (QMS) in accordance with GMP and regulatory requirements, ensuring continuous improvement through cross-functional collaboration. Oversee document control systems, including key records such as the Master Validation Plan and Site Master File.

Develop and implement validation programs for equipment, instruments, and systems. Ensure all necessary testing is performed prior to product release and that materials are evaluated and approved before use. Supervise the management of reference samples, record retention, and the destruction of expired or rejected materials.

Lead the training function by identifying organisational training needs, delivering sessions, and assessing effectiveness, particularly regarding compliance with the PIC/S Guide to GMP. Address re-training needs when non-compliance is identified.

Review batch records and coordinate quality assurance activities to support timely release of products. Act as the company’s Authorised Person, ensuring released products meet marketing authorisation requirements.

Oversee quality-related investigations, including change controls, deviations, OOS events, and corrective/preventive actions. Approve label proofs and artwork, and ensure all packaging and bulk materials meet quality specifications.

Manage audits and inspections by regulatory agencies and clients, ensuring site readiness and compliance with both local and international regulations. Conduct internal audits, communicate findings to relevant departments, and implement corrective actions.

Qualify and monitor vendors, including contract testing laboratories. Investigate market complaints, manage product recalls, and conduct root cause analysis. Complete annual reviews of product quality issues to drive continuous improvement.

Requirements:

Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field (Master's degree is a plus!).

3+ years of proven QA leadership in GMP pharmaceutical manufacturing.

Strong knowledge of PIC/S GMP and regulatory frameworks.

Audit experience, validation knowledge, and training implementation skills.

If you are ready to take on a pivotal role ensuring the highest quality standards in pharmaceutical production, apply now to join our team in Warriewood.