Quality Assurance Manager

2 weeks ago

Brisbane, Queensland, Australia Pharma To Market Full time

Remote role serving business across APAC

Pharma To Market is an award winning Australian regulatory affairs and pharmacovigilance consulting company entrusted by some of the world's leading life science companies. We believe that establishing relationships built on trust, transparency and reliability are at the core of our and our clients' success.

In this position, you will be responsible for leading the Quality Assurance (QA) function, driving implementation of continuous improvement initiatives for the company's Quality Management System (QMS), management and control of QMS related documents and ensuring ongoing compliance with applicable regulatory requirements. As an excellent communicator, skilled in risk-based thinking, you have an exceptional ability to collaborate with cross-functional teams to proactively identify, analyse, and address potential risks and opportunities in a structured and coordinated manner within a QMS framework.

In addition to QMS functions, the role includes hands-on in operational QA tasks, balancing strategic oversight with direct involvement in daily quality operations. This role is ideal for someone that is a strong leader with a keen eye for detail, a passion for maintaining the highest quality standards, and a desire to contribute to a highly regulated and technical environment.

You'll be the expert in leading audits, managing quality events, and driving proactive solutions.

Examples of role responsibilities:

  1. Develop and implement a comprehensive Quality Assurance strategy aligned with the company's business objectives.
  2. Plan and execute internal audits according to an annual schedule and assist in addressing any findings or recommendations.
  3. Prepare for and participate in external audits by third parties, including clients and health authorities, and assist in addressing any findings or recommendations.
  4. Manage QMS documents, including their creation, revision, review, and implementation in accordance with regulatory guidelines, industry standards and client requirements.
  5. Implementation and monitoring of key performance indicators and management of day-to-day QMS activities.
  6. Liaise with internal stakeholders/customers to support QMS processes and implement QMS improvements.
  7. Handling and ensuring timely resolutions of CAPA (Corrective Action and Preventive Action) and Deviations/NC (Non-Conformance) process and report performance to Directors including the need for improvement & resources.
  8. Manage PTM's internal vendor qualification program, including auditing/qualification of new vendors and periodic requalification/auditing of existing vendors. Complete vendor qualification questionnaires requested by Clients.
  9. Promote and contribute to a culture of continuous improvement and quality awareness among the organisation.

Experience with the following would also be highly regarded:

  1. Qualification of product batch review process and approval.
  2. Review and approve batch records, certificates of analysis, and product release documents.
  3. Conducts, reviews and approves Product Quality Reviews, deviations, OOS, change controls, risk assessments and trend analysis reports.
  4. Oversee GMP clearance documentation and processes.

What you need to bring:

Qualifications, Skills and Experience

  1. Tertiary qualification in life sciences.
  2. Diploma of Quality Auditing and experience working with ISO 9001 certified QMS, including experience conducting audits on Quality Systems.
  3. A minimum 5 years' experience as part of a quality team, ideally at a management level.
  4. Experience working in the pharmaceutical industry (particularly with OTC and prescription medicines) with sound knowledge of Good Manufacturing Practice (GMP) and Good Distribution Practices (GDP).
  5. Strong knowledge of Computer Systems Validation processes including Good Automated Manufacturing Practice (GAMP 5) methodology etc.
  6. Proficiency in QMS software and document control systems.
  7. Experience with QMS management or setup.
  8. Strong communication and problem-solving skills.
  9. Managing GMP documentation and processes.
  10. Ability to work in a fast-paced, regulated environment and able handle multiple projects and priorities.

Please note: whilst this business operates from Brisbane, this role may be fulfilled from anywhere within Australia. However, you must be eligible to work in Australia.

Please complete the seek application process and ensure that you provide a Cover Letter including your capability and capacity to work remotely for the role from anywhere in Australia.

If you are an enthusiastic and self-motivated quality assurance professional with a drive to learn new skills and to succeed, this is the position for you

How do your skills match this job?

Your application will include the following questions:

  • Which of the following statements best describes your right to work in Australia?
  • How many years' experience do you have as a Quality Assurance Manager?
  • Have you worked in a role which requires a sound understanding of Good Manufacturing Practices (GMP)?
  • How many years of auditing experience do you have?
  • Have you worked in a role which requires a sound understanding of ISO 9001?
  • What's your expected annual base salary?
  • How much notice are you required to give your current employer?
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