Overview
Consultant – Quality & Compliance Jobs in Melbourne, Victoria, Australia at ProductLife Group
Title: Consultant – Quality & Compliance
Company: ProductLife Group
Location: Melbourne, Victoria, Australia
We are seeking an experienced and detail-oriented Quality and Compliance Consultant with strong technical expertise in pharmaceutical/biotech Quality Management Systems (QMS). The ideal candidate will bring a solid background in project management with hands-on quality systems management experience. Familiarity with Australian regulatory expectations and guidelines (e.g., TGA) is highly desirable.
Key Responsibilities:
Act as Project Team Leader, participate in assigned projects and support project teams as required.
Supervise, mentor and coach other members of the project team as required.
Provide project management support including client liaison, project scoping and proposal development, project team resourcing, project management and delivery and client follow up.
Support clients by managing and overseeing their Quality Management System (QMS) activities including deviations, CAPAs, change controls, document control, and risk management.
Perform internal and external audits, including audit readiness activities, CAPA follow-ups, and regulatory inspection support.
Perform release to market and/or distribution.
Lead or support QMS-related projects including development, system improvements, compliance gap assessments, and regulatory updates.
Maintain up-to-date knowledge of regional regulatory requirements, especially TGA guidelines and others relevant Australian standards.
Manage and complete TGA GMP Clearance applications on behalf of clients.
Collaborate cross-functionally with other teams to drive quality culture and continuous improvement.
Required Qualifications:
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field. Advanced degrees preferred.
Minimum 5 years of experience in a quality/compliance role in the pharmaceutical, biotechnology, or medical device industry.
Proven expertise in managing quality systems.
Strong knowledge of GMP regulations and guidelines (TGA, PIC/S, ICH).
Experience with audit execution and inspection readiness for regulatory agencies.
Proficiency in using electronic QMS tools and documentation systems.
Excellent project management, communication, and cross-functional collaboration skills.
Experience working within or alongside Australian regulatory frameworks is a strong advantage.
Desirable Skills:
Experience with global regulatory audits and multinational QMS environments.
Ability to work independently and lead multiple initiatives in a fast-paced setting.
Previous consulting experience.
Certification in Quality Assurance, Project Management (PMP), or related fields
