Senior Quality Assurance Specialist

1 week ago

Australia CSL - Australia Full time
About the Role

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at CSL - Australia. As a key member of our Quality Assurance department, 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.

Key Responsibilities
  • Develop and Maintain Quality Systems

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

Negotiate and Establish Quality Agreements

You will 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 Supplier Qualification

You will provide guidance on external supplier qualification and material introduction/enrolment considerations during product development and manufacturing processes within the Change Management framework.

Perform Quality Systems Audits

You will 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

You will 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.

Requirements
  • Education and Experience

A degree in a relevant business or science, or equivalent education and experience, and at least 5 years' experience in a GxP environment in the pharmaceutical industry.

Regulatory Knowledge

A thorough understanding of required regulations, including but not limited to FDA, PiC/S, and European regulation, Therapeutics Goods Authority, and Canadian Health Authority.

Leadership and Quality Systems

Demonstrated leadership and knowledge of Quality Systems and Supplier Management.

Industry Knowledge

Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations.

Communication Skills

Demonstrated ability to interact with and gain the support of senior management, global partners, and cross-functional teams.

Regulatory Environment

In-depth knowledge of the regulatory environment for the manufacture of drugs.

Global cGMP Regulations

Must possess thorough knowledge of global cGMP regulations and ISO standards.

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