Quality Manager, R&D CMO and Supplier Management
Job Type: Full time
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.
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
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