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.

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.

• 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.