Head Of Quality Assurance

Reporting directly to the Site Head of Quality, this position provides leadership, directs and leads the Quality Assurance organization and all Quality Assurance related programs and activities to support clinical and commercial manufacturing, testing, and release of biopharmaceutical products. The Quality Assurance department is responsible for the development, implementation, auditing of and reporting on the status of the Quality Systems of the Thermo Fisher Scientific Brisbane, Australia site. Further the QA and Quality Control tasks in relation to the manufacturing operations and batch disposition decisions. This position is a leadership position managing, developing, mentoring, and overseeing. The QA function, under the direction from the head of Quality, oversees the direct engagement of the site Quality department with the biopharmaceutical manufacturing process and is responsible to achieve and maintain compliance with all relevant national and international regulatory requirements and to thereby ensure the site's "Right to Operate".

• Key Responsibilities

Oversee and provide leadership to the Quality Assurance function.

Accountable for Quality Assurance oversight to ensure the corresponding phase appropriate cGMP compliance according to regulatory expectations.

Responsible for the effective implementation, monitoring and maintenance of the Pharmaceutical Quality System, ensuring the appropriate authorisation of written procedures and documents, the monitoring and control of the manufacturing environment, review / approval of relevant deviations, CAPAs, change controls and other quality system records and plant hygiene.

Responsible for quality systems on site, including (but not limited to) Customer complaint management, Supplier Management, Material Management, Deviation Management, Change Control, Document Management and Audit Management, and including advocating for continuous improvement of these systems

Responsible for ensuring that each batch of medicinal product has been manufactured and checked in compliance with the local / regional / national / international laws in force and in accordance with requirements of the Marketing Authorisation, as required.

Accountable for the timely disposition of drug substance to allow shipment to customers or internal sites.

Initiate, lead and support improvement projects together with operational departments to address, prevent and reduce deviations

Fully collaborate with the Quality Audits Manager to host and lead internal and external audit / inspections

Leads a team of managers and professionals within Quality : motivating, hiring and developing employees, assigns work, provides feedback, mentoring and coaching and taking disciplinary action when required.

Manages team performance through effective key performance indicators, targets and goal settings and provide this data to Site Leadership and the Global Quality organisation, as needed.

Completes resource and human resources planning activities in line with business requirements.

Supports the business development functions, providing appropriate Quality input to prospective customers, including the demonstration of compliance through audit.

• Hiring, coaching and mentoring professional Quality staff
• Advocate EH&S compliance

Complete any other legitimate duties requested by immediate manager.

• Frequent Contacts

Internal

• Operations
• Project Management / Business Management
• Global Quality
• Regulatory Affairs

External

• Customers
• Health Authorities / Regulatory Agencies
• Suppliers / Vendors
• Minimum Requirements / Qualifications

Qualifications & Experience

• B.S. in a scientific / technical discipline with at least 5 years' experience in a Quality leadership role or a significant leadership position within the biological and / or pharmaceutical industry
• Demonstrated quality leadership for a Contract Manufacturer preferred.
• Confirmed operational leadership qualities within a commercial manufacturing setting
• ideally 5-10 years' experience leading successful teams
• Skills & Attributes
• Determined, enthusiastic and driven
• A true leader and someone who has led transformational projects
• Strong management skills in order to manage and develop staff
• Must be able to handle ambiguity and to interact with and influence the most senior levels of the organization
• Dynamic leadership with a balance between Quality and business mind-set
• Other Job Requirements

Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment