Quality Manager (Part-Time, Fully Remote)

Company Description

Tissue Repair Ltd is an Australian biopharmaceutical company specializing in advanced wound healing technologies for the chronic wound and cosmetic procedure markets. At the core of its innovation is a unique, biologically active ingredient designed to stimulate the body’s natural repair pathways by mimicking a yeast infection. This breakthrough allows for the development of topical products targeting a broad range of wound care conditions. Tissue Repair is committed to delivering innovative solutions that significantly improve healing outcomes and enhance the quality of care for patients.

Quality Manager (P/T – 3 days/week/Fully Remote)

We are looking for an experienced Quality professional to join our small team. This role is ideal for someone who enjoys building fit‑for‑purpose quality systems in a growing biotech environment. You will support day‑to‑day quality processes while guiding the organisation in establishing and maintaining phase‑appropriate Quality Management System (QMS) capabilities aligned with our development stage.

You will work collaboratively across CMC, Clinical, Operations, and external partners to ensure compliance, operational readiness, and continuous improvement as the company advances from late-stage development to early commercialization.

 Key Responsibilities

• Build, scale and continuously improve a QMS that meets multi-jurisdictional requirements.

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• Manage and optimize the Pharmaceutical Quality System (PQS) to support a hybrid drug–device development environment, ensuring alignment with cGMP and GLP (21 CFR 210/211), ICH Q10, FDA Quality System Regulation (21 CFR 820), and ISO 13485, including oversight of documentation, compliance, and quality risk management activities.
• Ensure all quality processes scale appropriately with clinical development stage, balancing compliance with practicality.
• Oversee document control, change control processes, deviations and CAPAs
• Prepare for and support internal and external audits.
• Partner with internal teams to guide compliance expectations and phase‑appropriate quality best practices.
• Implement continuous improvement initiatives that enhance quality while keeping systems lean and effective.
• Provide quality oversight across manufacturing, testing, and clinical supply chain processes.
• Post-market surveillance in compliance with local regulatory authority timelines, including managing recalls or safety alerts.

 About You

• Bachelor’s or higher degree in Pharmacy, Science, Biotechnology or Engineering
• 5+ years of Quality experience in biotechnology, pharmaceuticals, biologics, medical devices, or related regulated industries.
• Working knowledge of FDA Quality Systems Regulations (QSR), including 21 CFR Part 820, 21 CFR Parts 210/211, and relevant quality guidance.
• Familiarity with TGA requirements, including GMP for medicines, listed medicines (ARTG) expectations, and Australia‑specific quality and compliance frameworks.
• Familiarity with FDA 510(k) submissions and an understanding of device‑related quality expectations such as design controls, risk management, and documentation requirements.
• Familiarity with CE marking quality frameworks, such as EU MDR/IVDR, ISO 13485, and European conformity assessment pathways.
• Ability to operate within a global quality landscape, including ICH guidelines (ICH Q-series), PIC/S GMP, WHO guidance, and region‑specific regulatory standards.
• Demonstrated experience establishing or maturing phase‑appropriate QMS in an early‑ or mid‑stage biotech environment.
• Strong working knowledge of GMP, with exposure to GCP and GLP preferred.
• Excellent communication and organisational skills, collaborative with a practical, risk‑based mindset, ability to operate independently and a hands‑on approach to Quality.
• Comfortable working in a dynamic, evolving environment with the ability to balance compliance, science, and operational pragmatism.