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, accountability and continuous improvement
About You
To be successful in this position, you will ideally have:
- Tertiary qualifications in Pharmacy, Pharmaceutical Science, Chemistry, Biotechnology, Science or a related discipline
- Demonstrated QA experience within a pharmaceutical, complementary medicines or other highly regulated GMP manufacturing environment
- Previous experience in a QA Manager, Senior QA, Quality Lead or similar position
- Strong knowledge of TGA and PIC/S GMP requirements
- Hands-on experience managing QMS, deviations, CAPA, change control and investigations
- Experience preparing for and participating in regulatory and customer audits
- Knowledge of validation, qualification and GMP documentation requirements
- Strong understanding of manufacturing quality systems and quality risk management
- Previous experience leading or mentoring QA personnel
- Excellent written communication and documentation skills
- Strong attention to detail with the ability to balance compliance requirements with manufacturing priorities
Experience within complementary medicines, nutraceuticals, tablets, capsules, powders, liquids or similar pharmaceutical manufacturing will be highly regarded.
What's on Offer
- Permanent full-time leadership position
- Established pharmaceutical manufacturing environment
- Opportunity to take ownership of site quality systems
- Exposure to a broad range of manufacturing and packaging operations
- Work closely with Production, QC, Regulatory and senior management
- Opportunity to drive quality improvements and strengthen GMP compliance
- Competitive salary package based on experience
- Western Sydney location
Apply
If you are an experienced pharmaceutical Quality Assurance professional looking to take the next step in your career, we would like to hear from you.
Click Apply Now and submit your current resume.
For a confidential discussion regarding the opportunity, please contact iHarbour Consulting.
iHarbour Consulting
Connecting quality people with quality organisations.
Pay: $135,000.00 – $165,000.00 per year
Work Location: In person
