Quality Assurance Director for Pharmaceutical Operations

3 days ago

Sydney, New South Wales, Australia Ambition Full time

Ambition is a leading pharmaceutical company specializing in OTC healthcare products, seeking an experienced Quality Assurance Director to lead our quality assurance and regulatory affairs.

The Role:

  • Lead a team of four professionals focused on quality assurance, regulatory affairs, and technical aspects of product development.
  • Ensure all products meet required quality standards throughout the lifecycle, from development through to post-market surveillance.
  • Oversee the development, implementation, and continuous improvement of quality assurance systems, ensuring compliance with Good Manufacturing Practice (GMP) and other relevant standards.
  • Act as key point of contact for regulatory affairs, liaising with authorities as needed to resolve compliance matters.
  • Perform audits of local and international contract manufacturers to ensure adherence to GMP and quality standards.
  • Manage customer complaints, change control processes, and any adverse events reporting.
  • Ensure product specifications and manufacturing/testing procedures align with international standards and regulations for various markets.

About You:

  • Extensive experience in senior quality assurance or regulatory affairs roles in pharmaceuticals, consumer healthcare, or medical devices.
  • Strong knowledge of GMP and regulatory frameworks, particularly in consumer healthcare and medical devices.
  • Experience with regulatory bodies like TGA and working with local and international contract manufacturers.
  • Proven leadership skills, able to manage and mentor a team while working autonomously.

What We Offer:

  • Competitive $140,000 - $180,000 annual salary, reflecting your expertise and qualifications.
  • Opportunities for professional growth and development in a dynamic industry.
  • International travel requirements to Europe and Singapore may apply.

Please note that we value candidates who are committed to excellence and share our ambition for quality and innovation in the pharmaceutical sector.

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