Team Leader, QC (Logistics/Stability)
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!
To coordinate and ensure QC team objectives are achieved, and operational decisions made and executed in a timely manner.
Provide direction and co-ordination of all activities to ensure compliance with regulatory requirements and company SOPs. To ensure that all scheduling requirements are met, in conjunction with other departments where required. Mentor and develop staff technically and professionally. Supports efforts across multiple areas to accomplish goals, providing guidance and influencing the organization. Provide technical leadership and to co-ordinate the activities of work allocated to the team of analysts; specifically, the testing of Quality Control samples, Raw Materials, and to support validation studies.Major Accountabilities
- Provides strong leadership on safety and creates a positive safety culture. Ensures safety is always on the front line.
- Schedule the activities of the team in accordance with the Lean Lab solution; monitor and approve time and attendance; ensure training/competence completion; perform 1-1s and development planning; manage performance of all associates. The monitoring of associated KPIs being used to adapt plans accordingly.
- Review and approve data generated from testing and to bring to the attention of the Team Manager and other site personnel test results and any trends, out of specification results. In addition, where appropriate perform the required transactions to release materials.
- Ensure that the maintenance and qualification of the specified laboratory and equipment within is up to date and at the required GMP standards. To ensure the use only of approved and validated test processes.
- Co-coordinate department cGMP systems, such as deviation management, closure of corrective and preventative actions, change controls and SOPs.
- Participate in improvement project teams where required driving quality decisions and provide advice and technical support where required. Coordinate completion of any resulting activities.
- Troubleshoot in the resolution of testing problems involving your team and relevant customers/suppliers. Demonstrate creative problem solving within cGMP constraints and align with best practice.
- Track the team ensuring that mandatory training is in place. To encourage optimal performance of staff through training, feedback every two months and development planning in conjunction with the Team Manager
- Bachelor’s degree in related science.
- cGMP background in the Pharmaceutical industry
- Minimum of 6 years’ experience in Quality Control testing techniques and industry practices
- Strong knowledge of lab safety & Data Integrity
- Strong communication skills with special emphasis on collaboration
- Experience within matrix / multi-disciplined team environment
- Experience with laboratory team scheduling