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.