Scientist, Process Excellence and Compliance (f/m)

It began with a promise. More than 100 years ago, CSL was formed to save lives using the latest technologies. In the century since, CSL Behring has grown into a global biotechnology leader, driven by that same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry. Our ability to innovate and deliver life-saving medicines for patients with unmet medical needs around the world has earned us a reputation for always putting patients first. We are CSL Behring and we are driven by our promise.

Are you passionate about regulatory compliance and eager to kickstart your career in a dynamic and supportive environment within Global Regulatory Affairs?

Join our team as a Scientist and play a crucial role in ensuring our organization's adherence to regulatory compliance. If you are detail-oriented, proactive, and ready to contribute to our compliance efforts, we would love to hear from you! Join our collaborative and inclusive work environment with opportunities for professional growth and development.

Apply now to join our team and make a difference in regulatory compliance!

To complete the team we are looking for a Scientist, Process Excellence and Compliance (f/m)

Role and responsibilities :

Procedural documents management

• Support procedural document preparation/review and lifecycle management
• Ensure compliance of GRA with local and global procedural documents
• Maintenance of the company online glossary with GRA definitions

Training

• Training analysis and assignment
• Maintenance of training presentations
• Onboarding newcomers to the department
• Facilitate classroom training sessions
• Support annual reviews of training curricula

Compliance activities

• Support regulatory agency inspections and audits including pre-inspection and related follow-up activities as needed
• Audit readiness activities including managing eStaff Record filing repository
• Support tracking of audits & inspections performed in GRA
• Support management of quality non-compliance events in GRA, such as deviations and CAPAs

Reporting and Analytics

• Preparation and/or review of various compliance reports
• Prospective monitoring of various compliance indicators

Other

• Management of the group inbox
• Project support activities as required
• Administrative activities such as scheduling meetings and meeting minutes
• Updates to SharePoint sites
• Meeting attendance
• Preparation, Review and Distribution of compliance Newsletter

General

• Applies practical knowledge of job area typically obtained through advanced education and work experience
• Works independently with general supervision to achieve operational targets with direct impact on departmental results
• Problems faced are difficult but typically not complex, sometimes requiring understanding of broader set of issues
• May influence others within the job area through explanation of facts, policies, and practices
• Select jobs may have formal supervisory responsibilities for support employees

Background education and experience

• Bachelor degree in a Life Science or Business Advanced degree in a Life Science (PhD,MD) or Business (MBA) an advantage.
• 1+ years regulatory experience in the pharmaceutical industry. Biologics Regulatory experience preferred.
• English is essential and German is nice to have

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.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

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

Do work that matters at CSL Behring!