Life Science Operations Director

7 days ago


Brisbane, Queensland, Australia KVALITO AG Full time

About the Role

KVALITO Consulting seeks an experienced R&D Project Lead to manage pharmaceutical research and development projects, ensuring compliance with regulatory requirements and optimizing project execution.

Key Responsibilities

  • Manage R&D projects, aligning them with scientific, business, and regulatory objectives.
  • Coordinate cross-functional teams, including Analytical Development, Formulation, Quality Assurance, Regulatory Affairs, and Clinical Operations.
  • Ensure compliance with GLP, GMP, GCP, and ICH guidelines, supporting regulatory submissions and audits.
  • Optimize laboratory workflows by integrating LIMS, ELN, and digital lab solutions to enhance efficiency and data integrity.
  • Monitor project risks, budgets, and resources, ensuring adherence to milestones and deliverables.
  • Act as the primary interface between business stakeholders, scientists, IT, and regulatory teams to deliver high-quality R&D solutions.
  • Support technology transfer and scale-up projects, ensuring smooth transition from lab-scale research to clinical and commercial manufacturing.
  • Report project progress and risks to senior leadership, providing insights and recommendations for decision-making.
  • Drive process improvements in R&D operations, leveraging best practices in Agile, PMI, and Lean R&D methodologies.

Requirements

  • Bachelor's or Master's degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Biotechnology, or Engineering Management.
  • Minimum 5 years of experience in R&D project management within the pharmaceutical, biotechnology, or medical device industry.
  • Strong understanding of drug development, analytical method validation, and CMC regulatory requirements.
  • Experience working in a GLP, GMP, ICH, and FDA/EMA-compliant environment.
  • Familiarity with LIMS, ELN, and QMS systems to support laboratory digital transformation.
  • Project management certification (PMP, PRINCE2, Agile) is a strong advantage.
  • Fluency in English (written and spoken); additional languages are a plus.

What We Offer

  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • Dynamic and supportive work environment
  • Recognition and rewards for outstanding performance


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