Job Information
ThermoFisher Scientific Team Leader, QA in Brisbane, Australia
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
About Us:
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer! Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 125,000 colleagues delivers an outstanding 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
Position Summary:
Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by TGA, FDA, EMA, ICH etc. This role reports to the Head of Quality Assurance, and is based in Brisbane. The role;s main focus us to manage a team including development, implementation, updating, auditing and reporting on the status of the Quality Systems and maintaining the TGA Manufacturing License.
Key Responsibilities:
Day to day management of the Materials Management Team, including planning, execution and reporting of all activities that drive key performance indicators
Establish and maintain the Materials Management function as an effective component of the Quality Assurance department that significantly contributes to the site’s management system
Lead the Materials Management Team to establish and maintain critical metrics related to all key systems owned by the team and ensure employee engagement and career development is maintained
Support the team in implementing continuous improvement (PPI) initiatives that realise cost savings and drive efficiency
Build effective working relationships and collaborate with key internal collaborators
Lead all aspects of the article code system, supplier change notifications, supplier qualification, supplier quality agreements, providing support to the site for training, consultation and article code approval
Participate and engage with Quality Management Reviews and assist in regulatory and client audits from readiness activities through to direct engagement with auditors, facilitating successful inspection outcomes
Collaborate globally and on site on the creation and implementation of policies and procedures
Lead the practical application of various risk assessments tools (i.e., failure mode effect analysis, fishbone diagrams, hazard and operability studies) and an ability to directly develop, participate, and advise others on the appropriate and efficient application of these processes
Day to day use of the Quality System, including Change Control, Deviations, CAPA, OOS/OOT, and Documentation Management
Collaborate with all internal departments together with Vendors, contractors, regulatory agencies, and customers
Skills and Experience:
Tertiary education in science or engineering-based field (i.e. biopharmaceutical manufacture, biotechnology, process technology) or relevant validated experience and/or Post Graduate qualifications
Min 1 yr of leadership expertise
Proven experience in the pharmaceutical industry aligned to Quality Assurance
In-depth knowledge of cGMP
Desire to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives
Strong written, verbal and interpersonal skills together with strong collaborative skills with the ability to establish trust with internal and external customers
Good knowledge of Microsoft applications, Smart Sheets – desirable
Continuous improvement attitude
Adaptability and excellent time management
Customer Focus and Integrity
Positive relationship builder and a natural problem solver
Quality orientation with the ability to interpret and apply GMP principles
Strong attention to detail and accurate completion of test records
Employee Benefits:
A competitive salary and performance related bonus structure
Access to Thermo Fisher’s global University
Exposure to market leading & innovative technologies
Career development opportunities in a leading global organization
We offer a competitive salary and performance related bonus structure, exposure to market leading and innovative technologies, career development opportunities in a leading global organisation, and access to Thermo Fisher's global University. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) .
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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.