Quality Manager - CDMO

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

Job summary

PharmSky Research in Australia seeks an experienced Quality Manager to lead and continuously improve the Quality Management System, ensuring GMP and global regulatory compliance. The role is hands-on, collaborating within a small team of the Quality & Regulatory group to support efficient daily operations.

The ideal candidate has extensive GMP quality experience, is adept at risk management, audits, and regulatory interactions, and will drive quality culture across the business while maintaining

Qualifications

• Bachelor’s degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, Pharmacy, Engineering or a related life science.
• 8–10 years’ experience in the pharmaceutical, biotech or medical device industry, including at least 5 years in a GMP quality role.
• Experienced in maintaining a QMS: document control, change control, deviations, CAPA and audits.
• Current knowledge of GMP and global regulatory frameworks, including TGA and PIC/S, including Annex 13 (Investigational Medicinal Products).
• Experience in regulatory inspections and client audits.
• Demonstrated expertise in quality risk management.
• Strong problem-solving, organisational and written communication skills, with the ability to manage multiple priorities.
• Full working rights in Australia.
• Experience as, or eligibility to act as, an Authorised Person for batch release.
• Pharmaceutical sterile manufacturing experience and working knowledge of PIC/S Annex 1 and contamination control strategies.
• Experience in a CDMO and/or contract testing environment.
• Familiarity with FDA, EMA and ICH guidelines and regulatory submissions.
• Experience as Responsible Person for Drugs, Poisons and Controlled Substances licences.

Responsibilities

• Continuously drive improvements of the QMS ensuring alignment with TGA, PIC/S and other global regulatory requirements.
• Define and monitor quality performance through metrics and governance processes.
• Own document control: review and approve SOPs, protocols, and other controlled documents with the relevant Area Managers.
• Implement quality risk management strategies and lead the resolution of quality issues including deviations, CAPA, OOS/OOT investigations, product quality complaints, recalls, making sure each is closed out in a timely manner.
• Ensure timely communication and escalation of quality issues to management.
• Act as an Authorised Person for certification and release of investigational medicinal products (IMPs).
• Review and approve qualification and validation programs for facilities, equipment and processes.
• Maintain PharmSky’s GMP licences and related permits,
• Act as the point of contact for all TGA correspondence, including application for licence variations, and audits.
• Define, lead and prepare for internal audit programs and host client and regulatory audits.
• Conduct vendor assessments, qualification and audits, and approve and monitor providers of outsourced GMP activities.
• Establish and maintain Quality Agreements with suppliers and clients.
• Support Business Development and Project Management with quality input to client projects, proposals and timelines.
• Ensure phase-appropriate regulatory requirements are met for development programs.
• Support regulatory submissions and client CMC documentation.
• Provide or organise staff training on GMP principles and the QMS and maintain training records.
• Uphold and champion a strong quality culture across the business.
• Follow company policies, treat others with respect and lead by example.
• Follow safe working procedures, use PPE as required, and report hazards, near misses and incidents promptly.

Job description

We are seeking an experienced Quality Manager with a can-do, results-driven attitude to lead and continuously improve our Quality Management System, ensuring compliance with the GMP and global regulatory frameworks, including TGA, PIC/S and international quality standards. Our ideal candidate will be a highly motivated, hands-on key member of the Quality & Regulatory team who is adept to working in a fast-paced, collaborative environment within a small team, contributing to the efficiency of our daily operations.

Key responsibilities

Quality Management System

• Continuously drive improvements of the QMS ensuring alignment with TGA, PIC/S and other global regulatory requirements.
• Define and monitor quality performance through metrics and governance processes.
• Own document control: review and approve SOPs, protocols, and other controlled documents with the relevant Area Managers.
• Implement quality risk management strategies and lead the resolution of quality issues including deviations, CAPA, OOS/OOT investigations, product quality complaints, recalls, making sure each is closed out in a timely manner.
• Ensure timely communication and escalation of quality issues to management.

Batch certification and release

• Act as an Authorised Person for certification and release of investigational medicinal products (IMPs).

Qualification and validation

• Review and approve qualification and validation programs for facilities, equipment and processes.

Licences, inspections and audits

• Maintain PharmSky’s GMP licences and related permits,
• Act as the point of contact for all TGA correspondence, including application for licence variations, and audits.
• Define, lead and prepare for internal audit programs and host client and regulatory audits.

Suppliers and clients

• Conduct vendor assessments, qualification and audits, and approve and monitor providers of outsourced GMP activities.
• Establish and maintain Quality Agreements with suppliers and clients.
• Support Business Development and Project Management with quality input to client projects, proposals and timelines.

Regulatory support

• Ensure phase-appropriate regulatory requirements are met for development programs.
• Support regulatory submissions and client CMC documentation.

Training and culture

• Provide or organise staff training on GMP principles and the QMS and maintain training records.
• Uphold and champion a strong quality culture across the business.

Workplace and WH&S

• Follow company policies, treat others with respect and lead by example.
• Follow safe working procedures, use PPE as required, and report hazards, near misses and incidents promptly.

Key selection criteria

• Bachelor’s degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, Pharmacy, Engineering or a related life science.
• At least 8–10 years’ experience in the pharmaceutical, biotech or medical device industry, including at least 5 years in a GMP quality role.
• Experienced in maintaining a QMS: document control, change control, deviations, CAPA and audits.
• Current knowledge of GMP and global regulatory frameworks, including TGA and PIC/S requirements, including Annex 13 (Investigational Medicinal Products).
• Experience in regulatory inspections and client audits.
• Demonstrated expertise in quality risk management
• Strong problem-solving, organisational and written communication skills, with the ability to manage multiple priorities.
• Full working rights in Australia.
• Experience as, or eligibility to act as, an Authorised Person for batch release.
• Pharmaceutical sterile manufacturing experience and working knowledge of PIC/S Annex 1 and contamination control strategies.
• Experience in a CDMO and/or contract testing environment.
• Familiarity with FDA, EMA and ICH guidelines and regulatory submissions.
• Experience as Responsible Person for Drugs, Poisons and Controlled Substances licences.

Personal attributes

• Leads by example and upholds GMP standards.
• Practical and hands-on, comfortable in an informal, fast-paced small team.
• Builds good working relationships with colleagues, clients, suppliers and regulators.
• Continuously seek improvements to quality systems and ways of working.