Quality Assurance Manager

2 weeks ago

Sydney, New South Wales, Australia On Q Recruitment Full time
About the Role

Our client, a pioneering organisation in the biopharmaceutical industry, is seeking a seasoned Quality Assurance professional to spearhead their Quality Assurance function. This is a unique opportunity to join a dynamic company at a pivotal stage and make a lasting impact on their future success.

About the Job:

This newly created QA Manager role will be instrumental in shaping and leading the Quality Assurance team. The ideal candidate will bring strong technical expertise in biological manufacturing, as well as exceptional leadership skills to drive cultural change within the team.

Your Key Responsibilities:

  • Develop, implement, and maintain a comprehensive Quality Assurance program, ensuring compliance with GMP, regulatory standards, and internal policies for viral vector manufacturing.
  • Lead, mentor, and manage the QA team, guiding them through the transition to a GMP-compliant environment and fostering a culture of quality and accountability.
  • Collaborate with cross-functional teams, including Manufacturing, QC, and Process Development, to integrate quality processes throughout the production lifecycle.
  • Manage deviations, CAPA, and change controls, ensuring timely resolution and continuous improvement.
  • Conduct internal audits and manage external audits by regulatory authorities and clients, ensuring inspection readiness in collaboration with the Chief Quality Officer.
  • Serve as a change agent within the organisation, driving quality initiatives and promoting best practices across the business.
  • Stay current on industry trends, regulatory updates, and advancements to support continuous improvement.

Requirements:

  • Bachelor's or Master's degree in Biological Sciences, Biotechnology, or a related field.
  • At least 8 years of Quality Assurance experience in a manufacturing setting, preferably within a biological manufacturing environment.
  • Strong knowledge of GMP regulations and global standards (FDA, EMA, etc.).
  • Proven leadership experience and solid problem-solving skills.
  • Excellent communication and interpersonal skills, with the ability to influence and drive change across teams.
  • Ability to thrive in a fast-paced environment and manage multiple priorities effectively.

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