Head Of Quality Assurance

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.

     

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JOB DESCRIPTION

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.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Our team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

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

Training of Quality and Operations personnel in the principles and application of cGMP pertaining to work that supports cGMP batch disposition

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.
• Knowledgeable of regulatory requirements (e.g. TGA/FDA/EMA/JP/ICH/PIC/S, etc.) applicable to biologics or pharmaceuticals. Ability to apply cGMP regulations and other international guidelines to all aspects of the position. Experience with regulatory inspections.
• Confirmed operational leadership qualities within a commercial manufacturing setting
• Proven in establishing new Quality processes and the consistent application through teams- 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 support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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COVID-19 Vaccination Update for U.S. & Canada Colleagues

• All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment.
• U.S. new hires (including those in Field Sales, Field Services and Customer Support – Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing.
• U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles.
• Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment.

accessibility disability access

Accessibility/Disability Access
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Learn more

eeo and affirmative action statement

EEO & Affirmative Action Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status. Learn more

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