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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

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