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Quality Manager

MedipaQSydney, New South Wales, Australia

13 days ago

Job description

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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 .

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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