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.

Consultant – Quality & Compliance

Apply