Head of Quality Assurance

1 week ago

Perth, Western Australia Thermo Fisher Scientific Full time
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 mindset

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.

  • Quality Assurance Officer

    1 week ago

    Perth, Western Australia Linkforce Engineering Full time

    WHO WE ARELinkforce is a leading integrated maintenance, engineering, and project services delivery business.Established for over 15 years, we pride ourselves in delivering positive outcomes across the mining, industrial, telecommunications and energy industries.THE ROLEWe currently have the opportunity for a Quality Assurance Officer to join us on a...

  • Quality Assurance Officer

    1 week ago

    Perth, Western Australia Linkforce Full time

    Linkforce is a leading integrated maintenance, engineering, and project services delivery business. Founded in 2007, Linkforce started operating in the Pilbara with a small crew of shutdown specialists and a single utility. Our group has now grown to an operational workforce of over 2,800 personnel with an extensive fleet of modern vehicles and equipment...

  • Quality Assurance

    1 week ago

    Perth, Western Australia Lynas Corporation Full time

    Our Rare Earths deposit in Mt Weld, Western Australia, is acknowledged as one of the highest-grade Rare Earths mine in the world and we operate the world's largest single Rare Earths processing plant in Malaysia - so you're joining a very unique team As a team member, you will be contributing to the sustainable supply of rare earths metals which are used in...

  • Quality Assurance Advisor

    1 week ago

    Perth, Western Australia Austal Full time

    About AustalDue to the Security Clearance required for this, applicants must be an Australian Citizen and eligible to obtain and uphold a Baseline Security Clearance.***About the PositionThis role, working within an established Quality system, will be responsible for leading and improving Quality Assurance activities within the Austal business, and where...

  • Quality Assurance Manager

    1 week ago

    Perth, Western Australia Bankwest Full time

    You have a naturally curious mind and can think strategically.- We are innovative with a focus on continuous improvement.- Together we can create better customer outcomes.- 12 month Secondment roleDo work that mattersThe Bankwest Chief Controls Office (CCO) is the control room for Bankwest, delivering consistency in customer service, operations, delivery,...

  • Quality Assurance Lead

    1 week ago

    Perth, Western Australia PERSOLKELLY Full time

    Opportunity for any experienced Quality Assurance Lead to join one of Australia's best employers. Initial 6 month contract. Kwinana location.PERSOLKELLY are one of Australia's largest and longest serving recruitment providers. Delivering both quality temporary and permanent options, we specialise in the recruitment of Engineering, Technical and Office...

  • Quality Assurance

    1 week ago

    Perth, Western Australia Nepean Building and Infrastructure Full time

    About UsNEPEAN Building & Infrastructure (a division of NEPEAN) represents iconic brands - Galintel, Weldlok and Galserv which services industries across Civil, Architectural, Mining, Construction and Galvanising.Our OpportunityTo support our ongoing growth, our Weldlok team are seeking a Quality Assurance and Control Officer to take responsibility for all...

  • Quality Assurance

    1 week ago

    Perth, Western Australia Lynas Corporation Full time

    Our Rare Earths deposit in Mt Weld, Western Australia, is acknowledged as one of the highest-grade Rare Earths mine in the world and we operate the world's largest single Rare Earths processing plant in Malaysia - so you're joining a very unique team As a team member, you will be contributing to the sustainable supply of rare earths metals which are used in...

  • Quality Assurance Manager

    1 week ago

    Perth, Western Australia The Technical & Engineering Network Full time

    Up to 130k plus superannuation Work with tier one clients Work with a WA companyTEN Recruitment is currently recruiting on behalf our client in the Food Manufacturing industry.They are looking to hire Quality Assurance Manager on a permanent basis.We seek a driven and experienced individual to spearhead the Quality Assurance and Food Technology role, working...

  • Quality Assurance Supervisor

    1 week ago

    Perth, Western Australia GenusPlus Group Full time

    3:1 Roster Highly competitive casual hourly rate Electrical background EssentialGenus Industrial Services offers innovative and fully integrated mechanical, and electrical & instrumentation services, bringing together solutions for all aspects of E&I and renewable energy projects.Position Accountabilities and Responsibilities:The Quality Assurance...

  • Manager Quality Assurance

    1 week ago

    Perth, Western Australia Fortescue Future Industries Full time

    Job no: 518818Work type: Full Time Fortescue EmployeeLocation: Perth Bennett St, Perth Fortescue CentreCategories: Technical & Engineering, Corporate Services_At Fortescue Future Industries (FFI) we are leading the global energy transition by developing a portfolio of renewable energy and green hydrogen projects. Our large scale, low-cost hydropower,...

  • Quality Assurance and Improvement Officer

    1 week ago

    Perth, Western Australia Murdoch University Full time

    Fixed Term (3 Years), Full Time (37.5 hours per week)- Classification H0405 | $64K - 78K plus 17% employer superannuation contributions- Salary Packaging opportunities- Ref: JR100709About UsThe Office of Quality and Standards provides essential services in relation to the quality, standards and compliance of Murdoch University as an Australian University...

  • Regulatory and Quality Assurance Lead

    1 week ago

    Perth, Western Australia Titan Recruitment Full time

    Job details: Posted 01 June 2023 SalaryExcellent day rate on offer LocationPerth Job type Contract DisciplineEnergy ReferenceJ45164Job description:About the RoleOur client, a global energy consultancy is looking for a Regulatory and Quality Assurance Lead to be based in Perth CBD. As an experienced QA professional, you will be responsible to provide...

  • Quality Assurance Officer

    1 week ago

    Perth, Western Australia NRW Holdings Limited Full time

    NRW Pty Ltd | Perth Metropolitan- Closing date: 10/07/2024About Us:NRW Holdings is proud to be one of the leading civil, mining, urban and drill & blast contractors in the Australian resources and infrastructure sectors. Our ongoing success is a direct consequence of the commitment we make to our clients, people and the communities in which we operate.NRW's...

  • Quality Assurance Officer

    1 week ago

    Perth, Western Australia Perth Metropolitan Full time

    About Us: NRW Holdings is proud to be one of the leading civil, mining, urban and drill & blast contractors in the Australian resources and infrastructure sectors. Our ongoing success is a direct consequence of the commitment we make to our clients, people and the communities in which we operate. NRW's capability includes projects for key clients across the...

  • Quality Assurance Manager

    1 week ago

    Perth, Western Australia Pacific Energy Full time

    Enjoy a newly created 9 day fortnight based in Perth Work on pioneering renewable energy projects across Australia Fantastic career opportunities in a rapidly expanding companyOur CompanyHybrid Systems Australia is one of the fastest growing and most trusted renewable energy partners in Australia. We specialise in grid-connected and off-grid renewable energy...

  • Quality Assurance Auditor EOI

    1 week ago

    Perth, Western Australia Ventia Full time

    Are you a Power & Energy industry professional looking for a new opportunity to work for one of Australia's largest dedicated infrastructure service providers?For more than 60 years, Ventia has been a trusted partner to some of Australia and New Zealand's largest energy providers and users. 2024 is an exciting time to join Ventia as they look to expand...

  • Head of Risk, Assurance and Compliance

    1 week ago

    Perth, Western Australia a&co Recruitment Partners Full time

    Contract Type: Full TimeLocation: Perth Western AustraliaIndustry: Executive SearchContact Name: Andrew TomichContact Phone: Date Published: 24Aug2023Are you a seasoned professional in risk management and compliance with a strong track record in the financial services sector? Do you have the leadership skills to guide a team and the strategic vision to...

  • Head Of Quality, Safety

    1 week ago

    Perth, Western Australia Asia Pacific Aircraft Storage Full time

    Alice Springs, Australia| Posted on 20/05/2024Work Experience5+ Years in Safety ManagementCity Alice SpringsProvince Northern TerritoryCountry AustraliaPostal Code0870About us Asia Pacific Aircraft Storage (APAS) is a leading company specializing in aircraft preservation and storage maintenance services.We offer secure and cost-effective solutions for short...

  • Quality Assurance Officer

    1 week ago

    Perth, Western Australia Pacific Energy Full time

    Collaborative, future-focused company culture Career growth opportunities Interesting manufacturing related to renewable energyHybrid Systems AustraliaTag LineDue to exciting acquisitions, Hybrid Systems Australia have an exciting opportunity for a Site Based Quality Assurance Officer within the Major Projects Division.Bullet Points Collaborative,...