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Get AI-powered advice on this job and more exclusive features.Direct message the job poster from ProductLife GroupWe 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:Bachelors 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.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 fieldsSeniority levelSeniority levelExecutiveEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at ProductLife Group by 2xGet notified about new Quality Consultant jobs in Melbourne, Victoria, Australia.Specialist, Insurance Administration and Underwriting QualityMelbourne, Victoria, Australia 3 weeks agoMelbourne, Victoria, Australia 3 weeks agoMelbourne, Victoria, Australia 1 week agoSenior Presales Consultant- Data Quality & Governance- HybridSouthbank, Victoria, Australia 5 days agoMelbourne, Victoria, Australia 1 week agoSenior Consultant - Risk & Controls AdvisoryMelbourne, Victoria, Australia 1 week agoSenior Quality Engineer TOSCA AutomationMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 1 month agoMelbourne, Victoria, Australia 2 weeks agoEmployment Consultant, Workforce AustraliaSouth Melbourne, Victoria, Australia 4 days agoMelbourne, Victoria, Australia 3 weeks agoPrincipal Management Consultant - Public SectorMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 1 week agoOrganisational Design Specialist or Lead (Senior Consultant or Manager) - People ConsultingMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 4 days agoMelbourne, Victoria, Australia 2 weeks agoRecruitment Consultant - Australia Wide OpportunitiesMelbourne, Victoria, Australia A$80,000.00-A$100,000.00 1 week agoMelbourne, Victoria, Australia 3 days agoSenior Associate Consultant/Consultant, Client RelationshipsMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 3 days agoMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 1 month agoFranchise Automotive Workshop & Operations ManagerEmployment Consultant, Disability Employment ServicesEmployment Consultant, Disability Employment ServicesOakleigh, Victoria, Australia 2 weeks agoWere unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr