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Posted: 8th May 2024

Head of Quality

Quality & Regulatory
Permanent full-time
Attractive remuneration package

About Cyclomedica

We are Cyclomedica, bringing light into Molecular Imaging since 1986. We have paved the way with Molecular Imaging solutions in Australia and around the globe. From innovation and development to clinical practice applications, we are the world leaders in functional lung ventilation imaging with our proprietary technology:  Technegas®.

Created and manufactured in Australia, our flagship product, Technegas®, has revolutionised diagnostic lung imaging and today transforms the lives of millions of patients in more than 63 countries around the world.

The site is FDA-licenced for drug and device manufacturing and holds a TGA cGMP certificate as well as an ISO:13485 certificate for the manufacture of its own CE-marked Class IIb /IIa medical devices.

About the role

We are seeking an experienced and inspiring Head of Quality to join our professional and committed team. This role is primarily responsible for leading Quality and Regulatory oversight activities in Australia. This senior leadership role will actively participate in providing direction and guidance in relation to Quality compliance to our Leadership team and the wider Quality team, whilst overseeing operational responsibilities.

Key Responsibilities

  • Ensuring the quality system requirements are effectively established and maintained in accordance with regulatory requirements
  • Reporting on the performance of the quality system to management with executive responsibility for review
  • Maintaining a state of inspection readiness
  • Ensuring all necessary testing is carried out and the associated records evaluated
  • Approval of specifications, sampling instructions, test methods and other Quality Control procedures
  • Managing and ensuring regulatory compliance
  • Managing Internal Auditing and External Auditing
  • Administering Risk Management Program
  • Managing customer complaints
  • Approval of written procedures and other documents, including Preventive Maintenance, Calibration, Validation and Qualification records
  • Maintenance of the out-of-specification, deviation, out-of-trend, change control and nonconformance programs.
  • Managing stability program(s)

About You

You are an exceptional leader who is passionate about making a positive difference. Excited by innovation and all things Quality, you are comfortable leading and motivating a team of professionals and building upon our progressive company culture. You enjoy working across the entire Quality spectrum, from providing and implementing a Quality roadmap to working with the team on grass roots activities.

Skills and Experience

  • Bachelor’s Degree in science or equivalent
  • At least seven years’ experience in GMP within Pharmaceuticals, Medical Devices, or related field (preferably both)
  • At least four years’ experience in a QA Management position
  • Thorough knowledge of and experience with applicable standards and regulations and authorities such as TGA and FDA
  • Proficient attention to detail, and excellent written and verbal communication skills
  • Outstanding leadership and problem-solving skills

Why Join Our Team?

  • Rare opportunity to join a company that manufactures both drug and medical device with exposure to FDA, TGA and European Notified Bodies.
  • Competitive and attractive salary package
  • Professional development opportunities
  • Health and wellness benefits such as Vaccination Program, Employee Assistance Program and discounted gym membership
  • Be part of an inspired and talented leadership team
  • Company culture that values respect, collaboration, innovation and ethics

You will be joining an organisation that embraces diversity & inclusion.

We are committed to providing products, services and solutions that improve clinical outcomes every day. If you feel the same, we invite you to submit your application using the form below!

We look forward to hearing from you,
The Cyclomedica Team

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