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.
Job Type: Full-time
Pay: $90,000.00 – $100,000.00 per year
Schedule:
- 8 hour shift
Work Authorisation:
- Australia (Preferred)
Work Location: In person