Global Quality Transformation Leader

4 weeks ago

Sydney, New South Wales, Australia On Q Recruitment Full time
Job Description

We are seeking a Senior Manager – Global Regulatory Affairs & Quality Assurance to drive quality initiative across our global business.

About the Role
  • This is an outstanding opportunity to join a company at a critical juncture, as they transition to a world-class medical device organisation.

As a key member of our team, you will play a pivotal role in driving cultural and operational transformation, embedding quality into the core of all processes and fostering a proactive, collaborative approach across departments.

Main Responsibilities
  • Cultural Transformation: Driving cultural transformation, embedding quality into the core of all processes, and fostering a proactive, collaborative approach across departments.
  • Regulatory Compliance: Overseeing regulatory and quality functions, ensuring alignment with ISO 13485, GMP, TGA, FDA, CE, and other global standards.
  • Maintenance of Manufacturing Operations: Providing regulatory guidance and quality oversight for overseas manufacturing facilities, supporting audits, resolving quality issues, and mentoring on-site teams.
  • Strategic Initiatives: Supporting the global transition to an electronic QMS.
  • Collaborating with internal stakeholders, including R&D, Sales, Marketing, and Supply Chain teams, to align quality initiatives with business objectives.
Requirements
  • A Degree in Life Sciences
  • A minimum of 8 years of quality assurance and/or regulatory affairs experience in the medical device industry.
  • Previous quality experience within a manufacturing environment.
  • The ability to influence stakeholders, build cross-functional collaboration, and drive accountability.
  • A proactive, hands-on approach, thriving in dynamic, fast-paced environments.
  • Previous line management experience.
  • Previous experience working with Asian countries will be valued.
Salary Information

An estimated annual salary for this position is $150,000 - $200,000 AUD.

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