Cell Therapies is a unique enterprise that develops and manufactures innovative immune therapies and regenerative medicine products for patients, researchers and clinical trial sponsors. As a business, we are contracted by other companies to develop and manufacture their innovative products for Australian and international patients. In the last 15+ years, we have established our excellence in the field and are now acknowledged as an industry leader in delivery of these ground-breaking treatments to patients.
Reporting to the Director of Quality, the Quality Assurance Manager is responsible for driving, establishing, and maintaining overall Quality Operations to ensure GMP compliance for the commercial manufacturing and distribution under license of cellular and tissue therapy products. The position requires risk based decision making capability, leadership competency and an ability to contribute to a collegiate and positive team environment.
· Oversight and approval for QA programs including Deviation, CAPA, Change Control, Suppliers and Internal Audits;
· Oversight of the batch review process;
· Ensuring day to day requirements for manufacturing support are met;
· Providing QA input on technical manufacturing issues;
· Management of communication with external clients, ensuring escalation and turnaround timelines are met;
· Delegate for batch release as required;
· Collation and assessment of Quality metrics;
· Managing a team of QA Specialists including responsibility for development plans.
· Minimum 3 years previous experience in senior roles in either QA or manufacturing;
· Excellent communication and presentation skills;
· Third level qualification in science, biological major preferred;
· Previous QA or manufacturing experience in GMP biologics manufacturing, cell therapy manufacturing experience highly regarded;
· Previous experience in leading a team of direct reports;
· In-depth, operational understanding of a GMP manufacturing facility and the interlinking between functional groups;
· Demonstrated ability in developing and managing scientific and technical staff;
· Effective and professional communication.
· Tertiary qualifications in Life Sciences;
· Demonstrated decision making ability in relation to high value, high risk products;
· Highly effective communicator;
· Demonstrated ability to influence at all levels of the business;
· A diligent and quality-driven approach;
· Ability to multitask and work autonomously as well as in teams.
The Salary offered will be commensurate with skills, experience and industry standards.
If you think you have what it takes to be part of a dynamic team for a company that is in a very exciting growth phase, then APPLY NOW!