Quality Manager, R&D CMO and Supplier Management

Job Description

The Opportunity:

Reporting to the Head of Validation, Capital Projects and CMO Management, R&D Quality Assurance (QA), the Manager of R&D CMO and Supplier Quality management will oversee CMO Quality (Contract Manufacturing Organization) and suppliers working on R&D projects.

You will manage and participate in the completion of Qualification Audits, Quality Agreements, leading a matrix team and assuring adherence to the Quality Assurance program, processes, phase appropriate GMP requirements and SOPs. You will serve as the R&D QA point of contact for recombinant, cell and gene therapy, and plasma third parties for supplier quality related issues.

You will collaborate with R&D stakeholders as well as with the broader CSL organization and our third party/ CMO partners to assure that our Quality Assurance program is implemented consistently.

Key Responsibilities Include:

• Provide global R&D QA oversight over CMO vendors to assure they adhere to the CSL Quality requirements, ensuring support for critical operations where appropriate
• Implement Global QA CMO/ Supplier Quality Program in collaboration with R&D Stakeholders and CSL Global Supplier Quality
• Maintain knowledge of new/updated regulations and trends
• Track CMO quality and escalate emerging trends to key stakeholders
• Act as the Responsible Person for CSL Behring to ensure all appropriate regulatory guidelines in the following areas are followed
• Implements strategic goals established by functional leadership
• Perform additional tasks as may be reasonably assigned in the course of business

To be successful in this position, you will require:

• Tertiary qualifications in a relevant discipline
• Minimum three years’ experience in leading a team.
• Minimum of 7 years’ experience in a GxP environment in the pharmaceutical industry with broad knowledge in GMP operations and Quality, ideally including specialist knowledge in Supplier Quality.
• Thorough understanding of global regulations including but not limited to FDA, PIC/S and European regulation, etc. Strong industry knowledge and auditing knowledge (internal and external) experiences within the industry. Must be comfortable working in a global, matrix organization.
• Good understanding of the importance and use of quality metrics.
• Excellent communication and organizational skills, as well as negotiation, influencing and collaboration skills.
• Demonstrated ability to work cross-functionally across internal and external stakeholders.
• Effective presentation and meeting skills within all levels of the organization and with external colleagues and collaborators.

To Apply:

Applications must address the selection criteria above and include a current CV and covering letter.

Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, working rights and other relevant checks form part of the candidate suitability

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.