Quality Assurance Manager

5 days ago

Sydney, New South Wales, Australia i-Pharm Consulting Full time $90,000 - $120,000 per year

Join a proudly Australian-owned organisation that specialises in the manufacture of high-quality pharmaceutical and cosmetic products. With a strong reputation for excellence and a commitment to regulatory compliance, this company operates a TGA-licensed manufacturing facility and supplies both local and international markets.

This opportunity is ideal for a seasoned Quality Assurance professional with extensive experience managing quality systems in a GMP-regulated pharmaceutical environment. As the Quality Assurance Manager, you'll lead site-wide QA and QC operations, manage a skilled team, and play a key role in driving compliance and continuous improvement across the organisation. Success in this role will require not only deep technical expertise but also a hands-on leadership style, a strong focus on cultural and procedural change, and the ability to influence and elevate quality performance across the site.

This role will be on site initially 5 days per week on site.

Responsibilities:

  • Leading the QA/QC function to ensure timely and compliant testing, batch release, and documentation review.
  • Managing quality-related activities including internal and external audits, deviation investigations, complaints, and change control.
  • Approving specifications, test methods, and quality documentation, as well as assessing and monitoring contract laboratories.
  • Ensuring validation activities, equipment maintenance, and qualification protocols are appropriately conducted and documented.
  • Supporting production teams to ensure products are manufactured in accordance with approved procedures and marketing authorisations.
  • Driving a strong compliance culture through team training, performance oversight, and continuous quality improvement initiatives.
  • Overseeing GMP agreements, regulatory inspections, and the maintenance of the Document Management System and quality records.

Skills:

  • Extensive experience in Quality Assurance within a GMP-regulated pharmaceutical manufacturing environment.
  • Proven leadership experience at a management level, with the ability to lead, coach and influence cross-functional teams.
  • Strong knowledge of TGA regulations and a commitment to upholding high compliance standards
  • Experience overseeing both Quality Assurance and Quality Control functions.
  • A background in working within or alongside contract manufacturing organisations (CMOs).
  • A hands-on approach to quality operations, with the ability to drive change and improve systems, procedures, and culture.
  • Excellent communication and stakeholder management skills.

Apply directly now, or send your updated CV to Ben Byrne at - OR

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