Quality Manager

**Quality Manager**
**Location: Sydney, NSW**
**Salary: $90,000 + Super**

**Medipaq is a fast-growing, purpose-driven pharmaceutical packaging company dedicated to delivering world-class, safe, and high-quality packaging solutions. We are seeking an experienced and passionate Quality Manager to lead our Quality Assurance and Compliance functions. This is a pivotal role ensuring our products and processes meet the highest standards of regulatory and customer expectations.**

**Key Responsibilities**:
**Quality Leadership & Systems Development**
- **Develop and implement robust Quality Management Systems (QMS) to achieve and sustain customer satisfaction.**:

- **Oversee all aspects of quality assurance, inspection, and non-conformance management.**:

- **Lead internal audits and drive a culture of continuous improvement across the organisation.**:

- **Train and supervise QA and QC Officers, and deliver GMP training to all relevant staff.**

**Regulatory Compliance & Certification**
- **Ensure full compliance with Therapeutic Goods Administration (TGA) and other relevant regulatory standards.**:

- **Act as Medipaq’s Authorised Person for the Release for Supply of Finished Products.**:

- **Manage the registration and ongoing compliance of the site with all applicable pharmaceutical certifications and regulatory requirements.**:

- **Facilitate external regulatory audits and ensure only approved products are released to the market.**:

- **Prepare and execute GMP agreements with suppliers and sponsors.**

**Product & Process Quality Oversight**
- **Authorise and review written procedures, batch documentation, and other quality-critical documents.**:

- **Oversee release of packaging materials, bulk products, and finished goods.**:

- **Monitor and control quality using statistical tools and quality metrics.**:

- **Implement and manage quality assurance activities including calibration, leak testing, inward and final inspections, and acceptance sampling.**:

- **Manage customer complaints and assist in recall procedures when necessary.**

**Validation, Storage & Supplier Management**
- **Prepare and manage the Validation Master Plan and associated schedules.**:

- **Monitor storage conditions for packaging materials, retention samples, and finished products.**:

- **Approve and monitor material suppliers and ensure all vendor inspections are completed as required.**:

- **Collect and review stability data to validate product shelf-life and support Product Quality Reviews (PQRs).**

**Continuous Improvement & Reporting**
- **Conduct regular Quality Review Meetings to ensure alignment across the business.**:

- **Lead preparation and review of Packaging Product Quality Reviews (PQRs) and incorporate bulk and stability data to finalise reports.**:

- **Maintain comprehensive records and ensure proper retention of documents and samples.**

**About You**:

- **Bachelor’s degree or higher in a relevant scientific or technical discipline.**:

- **Minimum 5 years’ experience in a quality role within the healthcare, pharmaceutical, or medical device sectors.**:

- **In-depth knowledge of GMP, TGA regulations, and pharmaceutical packaging quality standards.**:

- **Strong leadership and communication skills with the ability to train, influence, and lead cross-functional teams.**:

- **Detail-oriented with strong analytical and documentation skills.**

**Join us in creating a world-class packaging facility and culture — a place of joy, quality, and inspiration.**

Pay: $90,000.00 - $100,000.00 per year

Schedule:

- 8 hour shift

Work Authorisation:

- Australia (preferred)

Work Location: In person