Manager, Quality Engineering Process Life Cycle
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
Reporting into the Leader, Quality Engineering Process Life Cycle the Manager, Quality Engineering Process Life Cycle will perform Quality oversight activities for technology transfers, validation and life cycle management. The individual will be accountable for process and product quality of commercial products and of Capex projects of a manufacturing site.
- The incumbent will have demonstrated strong technical knowledge in the one or more areas of technology transfer, validation, life cycle management and cGMP compliance. They will support QA oversight of quality standards and systems aligned with the Engineering function in the above areas. They will be experienced in associated regulatory inspections
- This role will be responsible for activities in one or more of the following areas: all transfers to commercial, internal & external: TT Plans & Reports, Facility Fit Assessments, TT&V Business Excellence, Quality by Design (new and Legacy), Process comparability, PPQ (process, cleaning, filter etc.), Revalidation, CPV (data, statistic, KPI), Regulatory dossiers (validation), Annual Product Reviews, Process improvements, SOPs review & approval, Deviation (oversight), Changes, Inspections
- The incumbent will foster industry best practices and implement into site processes
The incumbent will work with the teams within of Global Engineering
The incumbent will work closely with his or her peers in Quality Engineering from the other manufacturing sites and ensure that the same principles and systems are applied across all CSL Behring manufacturing sites and that in all projects the appearance of the documentation in the stated areas is standardized.
The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization.
Conduct Quality Assurance Oversight activities including issue and Risk Management for local capital investment projects in area of responsibility (QbD, Technology Transfer, and Validation).
- Collaborate with internal partners for the execution of all capital projects – EU, AUS and US and others – to deliver projects on time and to the required standards and regulatory requirements.
- Delivers a consistent quality approach to facility and process design and development for capital projects
- Provide QA oversight on process within capital project.
- Support regulatory document submissions and pre-approval inspections for capital projects.
Conduct Quality Assurance Oversight activities including issue and Risk Management, for QbD, technology transfers, and validations
- Collaborate with peers in Engineering across manufacturing sites with internal partners for the execution of all technology transfers and associated validations to deliver these changes on time and to the required standards.
- Carries out Quality decisions regarding technical transfers and, validation activities are aligned with the direction of the organization.
- Participate in QbD and risks assessments and ensures up-to-date information throughout the total life cycleProvide QA oversight on and approve all protocols and reports linked to QbD, technical transfers and validation activities
- Ensure the development of a robust CPV program based on QbD and validation (KPI, statistics)
- Supports Process Engineering and Sites in improvements projects and provides QA guidance
- Ensures quality is represented appropriately for regulatory document submissions and regulatory inspections for technical transfer and the corresponding activities
Conduct Quality Assurance Oversight activities for Engineering Standards & Engineering Documentation and Knowledge Management in Validation
- Delivers to global engineering standards and processes consistent with regulatory requirements and industry standards (quality systems, policies, procedures and work instructions).
- Provides input to engineering on the content of an appropriate Documentation and Knowledge Management system for the Engineering function.
- Responsible for the approval of the documentation in the above areas, ensure compliance to GMP and that required standards are met. Ensure a harmonized appearance of all documentation across the entire capital project.
- Delivers against global standards for technology transfer and , validation
- Participate in deviations, SQUIPP assessment, ensure compliance of the final deviation reports.
- Facilitate global and local change controls
- Contribute to internal and authority pre- and post-approval inspections
• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
• Experience within a global matrix organization
• Knowledge of current Good Manufacturing Practices (cGMP) principles
• Knowledge of appropriate regulatory requirements
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.