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Quality Assurance Director

2 weeks ago

Sydney, New South Wales, Australia Ambition Group Full time

Ambition Group is seeking a seasoned Quality Assurance Director to spearhead quality and regulatory functions in our OTC healthcare products division.

Job Summary

This senior leadership role offers autonomy to drive and enhance quality assurance across the business, with a focus on pharmaceuticals, particularly OTC products. The ideal candidate will have extensive experience in regulatory reporting, quality assurance, and pharmacovigilance, as well as strong knowledge of Good Manufacturing Practice (GMP) and relevant standards.

The successful candidate will be responsible for leading a team of four professionals focused on quality assurance, regulatory affairs, and technical aspects of product development. Key responsibilities include ensuring all products meet quality standards throughout their lifecycle, developing and implementing quality assurance systems, and ensuring compliance with local and international regulatory requirements.

Main Responsibilities:

  • Lead, manage, and develop 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 GMP and other relevant standards.
  • Ensure compliance with local and international regulatory requirements, including TGA (Therapeutic Goods Administration) in Australia and other regulatory bodies in key international markets.
  • Act as the 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.
  • Lead qualification of new contract manufacturers and suppliers, ensuring compliance with company quality and technical specifications.
  • Manage customer complaints, change control processes, and any adverse events reporting.

Required Skills and Qualifications:

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