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Head of Quality
4 months ago
Quality and Safety
Melbourne
Full Time
Slade Health
Head of Quality - Slade Health
Slade Health is a provider of sterile compounding services from its TGA and Medsafe licenced manufacturing facilities in Australia and New Zealand.
As a well-established and respected industry name, Slade Health is a full-service provider of aseptically compounded pharmaceutical products including chemotherapy, analgesic, nutrition and antibiotic drugs for use by patients in hospitals.
Part of something bigger
***Being part of Icon Group, Australia's largest dedicated cancer care provider, with a global presence in Singapore, Mainland China, Hong Kong, UK and New Zealand. The Group is built on a strong but simple vision - to deliver the best care possible, to as many people as possible, as close to home as possible.
Here's why our people choose us
Purpose, at Pace:
We remain focused on continually expanding our services and making them accessible to more people across Australia and internationally.
Impact, at Scale:
We have a global reach and are growing every day. Here you'll know your work is making a difference.
Connection, at Heart:
Our work isn't easy but it's extremely important. Our secret ingredient is our incredible, connected, and talented people. And their secret ingredient is each other.
Opportunity, at Hand:
We're continually innovating. Every week brings changes, growth and new opportunities.
The Opportunity
***This key leadership role has recently become available as we position ourselves to continue to expand in the market. The Head of Quality leads all Quality and Compliance activities across our sites through an established and experienced Quality Team. They ensure that systems are in place and complied with so that Slade Health always operates in accordance with the applicable regulatory requirements for manufacture, supply and sponsorship of therapeutic goods. They promote and maintain the Slade Health's Quality Culture, prioritising patient welfare, compliance to regulatory expectations and the Pharmaceutical Quality System (PQS), and continuous improvement.
This position can be located at any of our Australian sites (Sydney, Melbourne, Brisbane, Adelaide) or at our site in Auckland, New Zealand.
- Act as a key contributor to the definition of the strategy for the business by understanding key regulatory trends and identifying key opportunities to drive improvement in compliance and quality.
- Define the requirements of Pharmaceutical Quality Systems (PQS) and to track, trend and communicate the performance of the system.
- Ensure all Quality activities meet or exceed all relevant regulatory requirements and expectations.
- Represent Slade Health on regulatory forums relevant to manufacture, supply or sponsorship of therapeutic goods.
- Ensure appropriate Manufacturing Licences for the therapeutic goods compounded by Slade Health are maintained including managing routine regulatory inspections.
- Project manage Quality projects.
- Effectively manage the Department on a day to day basis through sound leadership, guidance and open communication.
- Ensure all department KPIs are met.
- Tertiary qualifications in a Science Discipline or relevant industry experience.
- Minimum 5 years' experience in pharmaceutical manufacturing and GMP
- Ability to work in a fast moving manufacturing environment with contemporaneous release
- Demonstrated focus on business planning and strategic implementation
- Demonstrated knowledge of the regulatory expectations for manufacture and supply of sterile medicines and controlled drugs in Slade Health's key markets.
- Demonstrated ability to develop and coach a team to achieve set outcomes and desired behaviours.
- Demonstrated ability to effectively and independently solve problems whilst ensuring quality standards are not compromised.
- Proven leadership and people management skills.
