Posted: 11 June 2025
The Company:
The client of our BioMelbourne Network member mexec, is a biotechnology company with a unique, world-leading platform technology enabling site-specific drug delivery. This patented technology can be engineered into various product forms, one of which is currently in Phase II clinical trials for its lead indication.
The Opportunity
Reporting directly to the CEO, you will lead, manage, and direct all quality assurance functions within the company. As a senior leader within the business, you will:
- Define, promote, and embed a quality mindset across all levels of the organization to ensure excellence in every aspect of operations.
- Develop and maintain a robust QMS and author, review, and approve quality assurance documentation, including risk assessments, quality agreements with third parties, and compliance protocols.
- Establish appropriate quality specifications for products and develop processes to ensure compliance with these standards for functionality, reliability, and safety prior to release.
- Partner with department heads to ensure timely preparation and high-quality execution of CMC and product-related documentation, including MBRs, specifications, and SOPs.
- Maintain product quality by enforcing quality assurance policies and procedures aligned with local and international regulatory requirements.
- Clearly communicate quality standards and expectations to the QA team, product development, and other relevant departments to ensure alignment and accountability.
The Requirements:
- A degree in a relevant scientific discipline is essential. Advanced qualifications such as a PhD or MBA will be highly regarded but are not essential.
- Minimum of 10 years’ experience in the pharmaceutical, biotechnology, or medical device sectors, including at least 5 years in a senior management or leadership role.
- Experience with product development, QMS development, and quality assurance practices within the pharmaceutical or medical devices industries.
- Excellent leadership skills with the ability to make significant contributions towards risk management, future and strategic planning, and regulatory auditing activities.
- Up-to-date knowledge of ICH guidelines and international standards for medical devices.
- Familiarity with FDA and TGA regulations, international regulatory frameworks, and experience in preparing regulatory submissions such as INDs, NDAs, and other filings is highly desirable.
The Offer:
The successful candidate will join our client’s team at an exciting time and contribute to their successful transition towards growth. Appointment can be either full-time or part-time and renumeration will include an attractive base salary and access to bonus and share options schemes. To apply, visit www.mexec.com. Please email any questions you may have to careers@mexec.com, or if you are already registered with mexec, call 1300 063 932 to arrange a confidential discussion with Mark Thomas or Marilyn Jones.
