We are seeking an experienced and detail-oriented Quality Consultant with strong technical expertise in pharmaceutical/biotech quality systems.
* Act as a team leader, participate in assigned projects and support project teams as required.
* Supervise, mentor and coach other members of the project team as needed.
* 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 system 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.
* Lead or support quality-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 quality management 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 quality management 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.
Benefits:
This role offers the opportunity to work in a dynamic environment and contribute to the success of our organization.
Job Type: Full-time
Job Function: Quality Assurance
Industry: Pharmaceutical Manufacturing
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