Biopharmaceutical Quality Assurance Director

3 weeks ago


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

Our client, a pioneering organisation in the biopharmaceutical industry, is seeking a seasoned Quality Assurance professional to spearhead the development and implementation of a comprehensive Quality Assurance program. This newly created role will be instrumental in shaping the Quality Assurance function and driving cultural change within the team.

About the Role:

  • Develop and maintain a 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 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.
  • Drive quality initiatives and promote best practices across the business.

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.
  • Proven leadership experience and solid problem-solving skills.
  • Excellent communication and interpersonal skills, with the ability to influence and drive change across teams.


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