Posted 22 August 2021
The client, a Melbourne based biotechnology company, has developed a unique world leading platform technology that enables site specific drug delivery. Their technology involves development of patented polymeric prodrugs that can be engineered into various product forms. Now is an exciting time to join as they embark on an ambitious growth strategy.
The client is seeking an exceptional candidate to manage both the Quality Assurance for the company, and ideally project manage the development of a brand-new facility. Reporting directly to the CEO, as part of the executive management team, you will oversee all quality assurance matters and play a hands-on role project managing the development of the new facility in Melbourne. Your role will include input into design of GLP laboratories and GMP manufacture facilities for both API and finished product.
- Develop and manage the Quality Management System (QMS). Author, review & approve quality assurance documentation as required, including risk assessment and management.
- Design and implement changes to systems and processes to improve operational efficiency and enforce quality standards. Ensure compliance with national and international cGMP standards.
- Ensure continuous improvement of quality systems and processes through internal and external audit processes.
- Coach and counsel company staff to drive a quality culture and ensure all staff are trained on QMS.
- Work with other Heads of Departments to ensure CMC and product related quality documentation (e.g., MBRs, Specifications, SOPs) is prepared in a timely manner and to the standard required.
Facilities Project Management expertise (ideal – not essential)
- Work with architects and builders to ensure facility design meets regulatory requirements for GLP and/or GMP pharmaceutical manufacture.
- Conduct high level negotiations with external providers of facilities management services to achieve prompt, reliable, cost effective, quality services to the company.
- Oversee the engagement of contractors in accordance with company policy to undertake facilities related works.
- A degree in a related scientific discipline with a minimum of 5 years’ management experience in either the pharmaceutical, biotechnology or medical device industries. A PhD or MBA qualification an advantage.
- Proven experience in leading a team (preferably a Quality Assurance Team), and developing, coaching and fostering a quality centric organisational culture.
- Extensive knowledge managing quality systems in a pharmaceutical or related cGMP environment, ideally in both finished product and API manufacture.
- Strong leadership capabilities enabling you to successfully contribute to the client’s executive leadership team. Preferably demonstrated C-level capability and be able to operate at the executive level.
- Excellent project management capabilities, ideally in the development of a pharmaceutical facility.
The client will consider candidates with only Quality Management experience, as well as those capable of undertaking facility development. To join the client in this exciting new leadership opportunity, please email your cover letter & CV to firstname.lastname@example.org.
Confidential enquiries to Marilyn Jones on 1300 0 MEXEC.