We are looking for a Data Integrity QA Site Lead to join our team at CSL Behring Bern site. Partnering closely with the Global Data Integrity Business Process Owner and other Quality functions to continuously improve and standardize the DI processes and standards across the network of responsibility.

Responsibilities:

Advice and support site in Data Integrity related topicsSupport of the Global DI Program (e.g by supporting internal planning and alignment)Represent the Site Quality Assurance department as Subject Matter Expert in Data Integrity (responds e. g. to authority questions during inspections)Manage the Site DI Quality Master Plan for execution at the local levelLead local Data Integrity Steering CommitteeLiaise with the Global Core DI Team on relevant topics

Qualifications:

University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)5+ years or more in the field of DI in the pharmaceutical industryProfound Data Integrity background, including knowledge of relevant standards e.g.:Regulations and guidelines (21 CFR Part 11, EU Annex 11, PIC/S GMP Guide Annex 11, ICH Q9,Q10)Industry standards (GAMP 5 including DI related Good Practice Guides)Authority expectations on Data Integrity culture and implementation of standards (PI 041-1, MHRA GXP’ Data Integrity Guidance and Definitions; FDA: Data Integrity and Compliance with CGMP Guidance for IndustrExperience within a global matrix organizationStrog teamwork and communication skillsKnowledge of current Good Manufacturing Practices (cGMP) principleExperience in project managementLanguages: Fluent German and English requiredExperience in project managementPreferred experience working with CSV Technology and a fundamental understanding of IT concepts.

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.

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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.

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At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.

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