Quality And Regulatory Assurance Manager
Thermo Fisher Scientific Adelaide, Adelaide
Job Description
The Quality and Regulatory Manager will be part of a cohesive team responsible for leading the overall quality program for the site and product lines including production/process quality, supplier quality, customer driven project specific quality requirements and product regulatory requirements. In a direct aspect this role will be responsible for Deviations, CAPAs, Internal and External Audits, Customer Complaint and Change Control for all phases of manufacturing. The individual selected for will act as an effective leader in promoting quality directives, decisions and practices and will apply sound, systematic, problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues. Provide quality guidance, support, and leadership in the design, development, and design transfer processes for new product/service development projects; collaborating with other project team members to evaluate established requirements and identify measures critical for site adoption of programs. They will support the drafting, assembly, and filing of submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality, and are presented in a manner to facilitate review, and are in conformance with appropriate regulations and guidelines.
Key responsibilities will include, but not limited to:
What you will bring to the team:
What’s in it for you?
We offer a competitive salary and performance related bonus structure, recognition and awards program for individual and team performance or for taking an active approach to help our colleagues, culture and customers. Opportunities as a team member of a rapidly growing global organisation including access to training and development through Thermo Fisher’s Global University centre. Joining an extraordinary team of professionals working together to make a difference for our customers and for our world!
Special Conditions:
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
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Thermo Fisher Scientific