Job
- Level
- Lead
- Job Field
- IT, Project, System
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Salary
- from 6.807 € gross/month
- Location
- Berlin
- Working Model
- Onsite
Job Summary
In this role, you will lead the Data Governance team, develop policies for data integrity and security, and ensure compliance with regulatory requirements. You will manage successful gap analyses and projects for continuous improvement.
Job Technologies
Your role in the team
- Technical and organizational leadership of the Data Governance team as well as the further development of the area of responsibility.
- Establishment and positioning of Data Governance as a central point of contact for Data Integrity, Data Security, and Data Life Cycle Management.
- Definition, coordination, and harmonization of requirements for data governance, taking into account cross-site aspects.
- Development and implementation of pragmatic, audit-proof solutions to ensure data integrity and data security.
- Ensuring compliance with regulatory requirements for computer-based systems, GxP-relevant data, and the associated data lifecycle.
- Initiation, management, and tracking of GAP analyses as well as derived measures.
- Support during audits and inspections as well as assistance with non-conformance reports, CAPA, and regulatory requirements.
- Training and raising awareness among subordinate and adjacent areas on data governance-related topics.
- Regular reporting to the management of the quality unit on status, risks, progress, resource needs, and escalations.
- Provide operational support as needed for deviations, change controls, risk analyses, documentation, and other quality-related topics in the Data Governance environment.
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Our expectations of you
Education
- Completed degree in information technology, natural sciences, or pharmaceutical sciences.
Qualifications
- In-depth knowledge of relevant requirements and guidelines, particularly EU GMP Annex 11, FDA cGMP, GAMP, Data Integrity requirements, as well as risk-based quality management approaches.
- Strong quality awareness, analytical thinking, and high implementation competence.
- Strong communication skills and confidence in dealing with interfaces to Quality, IT, Technology, Production, and Infrastructure.
- Structured, independent, and results-oriented way of working.
- Ability to develop pragmatic and resilient solutions even in complex contexts.
- Excellent spoken and written English skills.
- Proficient in common software programs, especially Office 365, SAP/SAC, and ideally quality-related systems and documentation platforms.
Experience
- Several years of professional experience in the pharmaceutical environment related to CSV, Data Integrity, computer-based systems, IT/OT-related processes, and regulatory compliance.
- Leadership experience or proven expertise in managing complex, cross-departmental topics.
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What we offer
- Tariff-based salary (pay grade 13 with €6,807 gross monthly).
- 30 days of vacation per year including 1,200 euros holiday pay.
- 5 days of additional vacation (future entitlement).
- Annual performance (13th salary).
- Attractive social benefits of an innovative medium-sized company.
- The classification is carried out in accordance with the valid Federal Collective Agreement for the Chemical Industry.
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Topics You Will Work On
Job Locations
About Your Employer
Klosterfrau Berlin Gmbh
Der Klosterfrau-Spirit trägt das Unternehmen seit fast 200 Jahren und wird das auch in Zukunft tun: Tradition bewahren und Innovationen schaffen, um natürlich zu helfen.
Description
- Company Size
- 250+ Employees
- Company Type
- Established Company
- Working Model
- Onsite
- Industry
- Pharmaceutical Sector, Chemical Industry, Biotech