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!
The purpose of the position of VP R&D Quality is to lead a dedicated team responsible for quality oversight for the entire R&D organization through the use of the quality management system and associated processes.
This role is responsible for ensuring that the R&D Quality Policies and Processes are appropriate for the phase of R&D development and comply with corresponding regulations and guidances. There will also be an alignment to an enterprise approach for the application of the QMS within R&D.
Responsibilities cover the entire R&D GxP processes – GLP, GCP, GCLP, GVP and GMP as well as medical device and combination products regulations. Quality oversight is provided for toxicology studies, clinical development, clinical supply manufacture and packaging and medical device development. Quality oversight and management systems for Pharmacovigilance are also given.
The role is responsible for the leadership and co-ordination of all regulatory GxP inspections for the R&D teams.
This role is the most senior Quality role for R&D within CSL Behring and will work closely with the R&D Senior Leadership Team and will contribute to R&D decisions where required. This role will sit on a number of R&D governance meetings.
The role reports directly to the Global Head of Quality and is a member of the Quality Leadership Team.
1- To establish and maintain a set of clearly documented quality systems, standards and procedures defining the requirements for each stage of new and lifecycle development products and to advise on the application of these requirements, as needed.
2- Provide direction and oversight of the execution of the QMS specifically for Clinical and Combination Products/Medical Devices, Pharmacovigilance and Safety. Responsible for the execution of the global audit program for R&D, including internal systems and external vendors.
3- To lead and co-ordinate all internal and Health Authority inspections with the appropriate R&D teams. Leadership of inspection readiness plans and action plans post-inspection.
4- Accountable for Quality interfaces end to end in the development process from early phase research to GMP manufacture and commercial launch. Interface with other disciplines including Global Regulatory Affairs, Project Management, Operations and Commercial Operations as to ensure effective QMS transition between R&D and Commercial processes.
5- Chair the senior R&D Quality Management Review designed to ensure visibility and governance for the performance and improvement of the QMS to R&D leadership. Ensure Quality Management Reviews occur within the R&D GxP functions and issues are escalated to the senior R&D Quality Management Review.
6- To define and manage the process for Quality supplier qualification of vendors contracted by R&D, from service providers to CROs/CMOs, inclusive of routine quality governance as described in Quality Agreements, as applicable.
7- To participate and contribute to a number of R&D Governances – exact governances to be confirmed
8- To take an active role in educating R&D, Quality and R&D Project Management resources as to the quality requirements for the product development lifecycle.
- Requires a degree in a scientific, engineering, or related discipline. Postgraduate qualifications (Masters/PhD) are preferred
- Requires a minimum of 10 years of experience with equal exposure to both R&D and Quality in R&D. Quality experience should include audit participation at some level.
- Understanding of R&D clinical operations, clinical supply and Pharmacovigilance is essential.
- Experience of GMP Quality is also valuable
- Knowledge and experience of leading Health Authority inspections.
- Must be comfortable working in a global, matrix organization with cross-cultural experience
- Experienced at communicating and influencing at senior and executive management level.
- Expected travel is 30%