Data Integrity QA Site Lead

Vor 2 Tagen

Bern, Schweiz CSL Behring Vollzeit

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 topics
- Support 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 level
- Lead 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 industry
- Profound 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 Industr
- Experience within a global matrix organization
- Strog teamwork and communication skills
- Knowledge of current Good Manufacturing Practices (cGMP) principle
- Experience in project management
- Languages: Fluent German and English required
- Experience in project management
- Preferred experience working with CSV Technology and a fundamental understanding of IT concepts.

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

**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**:
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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