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Head of Quality Assurance

4 months ago

Brisbane, Australia Thermo Fisher Scientific Full time

The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.

Head of Quality Assurance is a pivotal leadership position based out of our Brisbane facility. The Thermo Fisher Scientific site in Brisbane, Australia is a state of the art facility, specializing in clinical and commercial manufacturing, and single use biologics technology. The Brisbane facility won the ISPE “2014 Facility of the Year” for Process Innovation, and is part of our global network of Biologics sites.

**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

Adhere to the Chain of Responsibility obligations under the Australian Heavy Vehicle National Law

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle complex scientific challenges, drive technological innovation and su