Quality Manager: GMP & Regulatory Excellence Lead

PharmSky Research; Melbourne; On-site; AUD 120,000 - 180,000; Full time

Job summary

PharmSky Research in Melbourne is seeking an experienced Quality Manager to lead and continuously improve the Quality Management System, ensuring GMP compliance and global regulatory alignment. You will manage document control, CAPA, inspections, supplier quality, and regulatory submissions in a fast-paced, small-team environment.

The role requires a Bachelor degree in a life science, 8–10 years in pharma/biotech/medical device with GMP quality exposure, and strong problem-solving and

Qualifications

• Bachelor degree or higher in a life science or related field.
• 8–10 years in pharma/biotech/medical device with at least 5 years in GMP quality.
• Experience maintaining a QMS: document control, change control, deviations, CAPA and audits.
• Knowledge of GMP and global regulatory frameworks (TGA, PIC/S).
• Experience in regulatory inspections and client audits.
• Quality risk management expertise.

Responsibilities

• Drive continuous improvements of the QMS aligned with TGA, PIC/S and global requirements.
• Own document control: review and approve SOPs, protocols, and other controlled documents.
• Act as an Authorised Person for certification and release of IMPs.
• Lead qualification, validation review for facilities, equipment and processes.
• Maintain GMP licences and be the point of contact for regulatory audits and correspondence.
• Establish and monitor supplier quality and quality agreements; support client projects with quality input.
• Support regulatory submissions and CMC documentation.
• Provide GMP training and maintain training records.

Skills

Quality management

Problem solving

Organizational skills

Written communication

Education

Bachelor degree or higher in Chemistry/Biochemistry/Pharmaceutical Sciences/Pharmacy/Engineering

Job description

PharmSky Research in Melbourne is seeking an experienced Quality Manager to lead and continuously improve the Quality Management System, ensuring GMP compliance and global regulatory alignment. You will manage document control, CAPA, inspections, supplier quality, and regulatory submissions in a fast-paced, small-team environment.

The role requires a Bachelor degree in a life science, 8–10 years in pharma/biotech/medical device with GMP quality exposure, and strong problem-solving and