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Job Title: Country Quality Lead Australia & New Zealand

Location:   Barangaroo, Australia

Job Type: Full time

About the Job

Our Team/ Overview:

Lead and manage the implementation and maintenance of the Country Quality system for GxP transversal process and new product introduction embarking all concerned country functions (responsible for Good Practices - GxP and health-regulated activities), ensuring quality of safe and effective products, information and services made available to meet patients and customers’ needs.

Main Accountabilities

1.   Commercial Operations

• Develops and implements the quality program in alignment with local and corporate objectives.
• Provides leadership and in the identification delivery of strategic quality initiatives across the business.
• Establishes effective working relationships across the local business, other country organizations, key customers, and suppliers
• Foster a sense of quality throughout the business.
• Established tracking systems to understand the health of the Quality System.
• Demonstrates a strong knowledge of local TGA and MEDSAFE GxP regulations and is able to lead local teams in projects impacted by these regulations.
• Establish and maintain quality across the local organization. This system must be complaint with the ISO9001:2015.
• Manage the product quality complaints process in accordance with local GxP and company procedures.
• Develops and carries out an audit program for the detection, and rectification of anomalies within the quality system, in accordance with the GMP, GWP, GLP, ISO and company procedures.
• Maintain an appropriate level of supervision of third-party manufacturing sites mitigates risk of the production of non-conforming products. Supervision may include the review of master production documentation, stability, and validation programs.
• Product is released for distribution in conformance to the registered specification. Maintain hold statuses appropriately
• Ensures an effective document management system is on place and works with others on the development of documentation.
• Provides leadership in the management of critical quality events such as recalls.
• Participates in the use of Quality Management techniques in the improvement of company processes.

• Work with key customers and suppliers to improve processes.
• Is involved in continued learning through participation in associations, conference, outside meetings and involvement within the Quality network.
• Ensures an effective management of repackaging systems is in place for some products sold in Australia and New Zealand.
• Provide support (as needed) to internal customers (Supply, Reg Affairs, Medical) relating to manufacturing and quality.
• Support product launches and transfers through developing a technical understanding of the products and manufacturing process to aid in the knowledge transfer, as well as creation of the technical transfer package.
• Provide training on quality systems as required.
• Provide support to other functions of the Quality team as required.
• Participate in local and global projects as required.

2.     People Management

• Recruit, develop and coach for high performance.
• Conduct and document regular performance reviews and an annual review as well as regular personal / career development discussions with direct reports, in line with agreed Sanofi Performance Management Process
• Build, guide, and coach teams to deliver work output within timeline & budget constraint

3.     MCO (Multi Country Organization) Leadership & Support

• Provide leadership and support with the South Korea and Australia New Zealand MCO as required and act as subject matter expert on assigned topics
• Serve as a technical reference for the assigned quality processes and promote best practices,
• Facilitate knowledge sharing and continuous improvement among quality teams

Candidate Profile

Essential Skills and Experience

• Essential Qualifications
• 5-10 years in the pharmaceutical industry in a similar role
• Medical terminology
• Product knowledge
• Knowledge of relevant codes of GxP
• Knowledge of Manufacturing and warehousing operations
• Knowledge of quality systems
• Document management
• Tertiary qualifications in life sciences or related field

Desirable Skills and Experience

Desirable Qualifications

• Presentation skills

• Negotiation skills
• Leading Teams / People Management
• Knowledge of SAP & Digital QMS Systems (VEEVA)\
• Registration with relevant Professional Association / Government Board

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

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