Your Role

You will play a pivotal role in ensuring the quality and compliance of materials and services provided by Suppliers, Service Providers, Third Party Laboratories, 3PLs, Distribution Business Partners and Contract Manufacturers.

You'll develop, implement and maintain robust supplier quality management processes to meet regulatory requirements and uphold the highest standards of product quality.

In this role you'll ensure the Supplier Management program (Quality Agreements, Performance Reviews, Change Notifications, Third Party Complaints, Enrolments, etc.) is executed successfully, including working closely to resolve deviations related to supplier material issues.

Your Responsibilities

• Develop and maintain a comprehensive external supplier qualification program to assess the capabilities and quality systems of potential suppliers.
• Negotiate, establish, and maintain quality agreements with external suppliers and service providers, defining expectations, responsibilities, and key performance indicators to ensure product quality and alignment with regulatory requirements and CSL quality standards.
• Provide guidance on external supplier qualification and material introduction/enrolment considerations during product development and manufacturing processes within the Change Management framework.
• Perform or assist with quality systems audits of potential and/or approved suppliers of raw materials, components, suppliers, contract manufacturers (CMO), and finished good distributors and service providers for the CSL sites.
• Conduct risk assessments for suppliers and establish risk mitigation strategies and drive continuous improvement initiatives including proactive identification of emerging risks in the supplier base. Identify areas for improvement and work with suppliers to implement corrective and preventive actions.

• A degree in a relevant business or science, or equivalent education and experience
• At least 5 years' experience in a GxP environment in the pharmaceutical industry.
• A thorough understanding of required regulations including but not limited to FDA, PiC/S and European regulation, Therapeutics Goods Authority and Canadian Health Authority
• Demonstrated leadership and knowledge of Quality Systems and Supplier Management
• Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations
• Demonstrated ability to interact with and gain the support of senior management, global partners, and cross functional teams
• In depth knowledge of the regulatory environment for the manufacture of drugs
• Must possess thorough knowledge of global cGMP regulations and ISO standards