Toxicology QA Manager
Biotechnology Clinical Life Sciences Pharmaceuticals
Location Brisbane, Australia
Salary £60-75K (AUD$100-125K)
Sponsorship + Relocation
A unique and exciting opportunity to work in the amazing gold coast of Australia has become available for a QA Manager. This growing company are involved in a wide range of toxicology and bioanalytical studies for drug development within the pharmaceutical and biotechnology industries.
As The Quality Assurance Manager in Toxicology, you’ll be managing the independent Quality Assurance (QA) audit program to assure compliance of the toxicology facility with internal policies and procedures as well as applicable international regulations and guidelines.
In this exciting QA Manager role for toxicology, your core responsibilities will be:
• Assure GLP compliance within a study, or in support of studies conducted by the toxicology facility
• Plan risk-based audit programs for the toxicology facility
• Manage a team of QA auditors, including adherence to the annual audit program ensuring internal and external stakeholder timelines are met.
• Conduct a wide range of audits, in accordance with QA risk-based processes, to ensure the quality and integrity of studies and facility are in compliance with regulatory and company quality system standards. These include audits of study activities (plans, in-life process, data, reports), facility processes and suppliers.
• Participate in and/or Lead audits of the Toxicology facility by Client representatives and Regulatory bodies
• Provide assistant and guidance to the operational departments during non-conformance assessment, investigations for improvement opportunities, investigation activities and corrective and preventative action and support improvement opportunities
• Timely and effective communication with internal staff on project status in an environment with rapidly changing priorities
• Provide technical leadership to junior colleagues to support their development
• Participate in and or contribute to GLP awareness and other training sessions.
• Ensure appropriate and timely escalation of quality issues, including issues of significant deviation with projects, to the Operational Managers and QA.
• Other duties as directed by Line Management.
• Oversee and manage recruitment, training, mentoring and performance management of QA team reports
• Work with the QA and management team on continuous improvement initiatives, specifically of QA systems and processes.
• Be a Key player in the Management Group.
This is an excellent opportunity to work with a global leader and strong presence within the Asia pacific region.
Based within a picturesque and beautiful part of Australia, this is truly an opportunity which is exciting, and one which doesn’t occur often. With Visa sponsorship taken care of and an attractive relocation package, this is a perfect opportunity to work in beautiful Australia in the heart of culture and natural beauty.
We look forward to receiving your application.