Quality Assurance Manager


Sydney, New South Wales, Australia

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Job Posted: 28/02/2017

Job Category:

Manufacturing, Chemical & Industrial / QA / Continuous Improvement

Job description:
Quality Assurance Manager
Full Time
Implement, enhance and manage the Quality Management System in Australia/New Zealand, in accordance with Novartis Quality Manual. Manage Quality Control in Australia/New Zealand.

Quality Assurance and Quality Control
•Define and scope the Quality Management System
•Implement, enhance and manage the Quality Management System in Australia/New Zealand
•Implement the Novartis Quality Manual, including performance of gap analyses
•Maintain Company’s Quality ISO Certificate 9001 &13485
•Manage and enhance the Release Activities in Australia/New Zealand
•Manage and develop direct reports
•Align the Business Strategy in Australia/New Zealand with the Global Quality strategy
•Lead compliance with global and local quality compliance measures, including remediation plans identified in quality audits.
•Ensure Supplier Management requirements are met.
•Support compliance activities
•Leverage and synergize with Novartis Quality resources in Australia/New Zealand and Alcon resources globally/regionally
•Manage document control relating to head office and local documentation
•Manage DCR and CAPA process
•Organise & Lead the Management Review
•Oversight of GxP Training Program
•Manage external audits (Health Authority and ISO certification) in Australia and New Zealand
•Approval and maintenance of GxP 3rd party suppliers including 3PL warehouse/distribution Miscellaneous
•Manage and develop direct reports
•Support compliance activities

Financial and Business Results:
•Improve Alcon’s perception of quality
•Coordinate Management Review Process
•Realise & meet agreed timelines for projects, product release and compliance requirements.

Strategy/Market Focus:
•Implement, enhance and manage Quality Management System across the Alcon/Ciba Vision business in alignment with Novartis Quality Manual
•Ensure the Quality Management System assesses risks that ensure no impact to patient, customer and business.

Operational Excellence:
•Management and enhancement of internal audit process, including direct involvement in audits
•Manage CAPA process
•Manage Document Control Review process
•Manage and enhance Quality Control
Degree in Quality Management, Quality or Science degree or solid experience working with quality or manufacturing English Strong knowledge of the local business, quality, customer needs and organization.
Results oriented, team player and able to work with all levels of the organization.
Solid communication, presentation, and writing skills.
Strong leadership and problem solving skills.
Able to identify issues and develop business-friendly solutions in line with the quality program. Business or marketed experience, good technical/IT skill are desirable