Validation & Compliance Manager - Master Data Systems at BI GmbH
Straße, Sachsen-Anhalt, Germany -
Full Time


Start Date

Immediate

Expiry Date

10 Jul, 25

Salary

0.0

Posted On

06 Jun, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Data Systems, Natural Sciences, Informatics, Presentations, Documentation, Software Validation, Preparation, Communication Skills, English

Industry

Information Technology/IT

Description

THE POSITION

Join the dynamic team at Global Business Services (GBS) Global Master Data Management (MDM), where we shape Master Data processes on IT platforms and deploy these solutions globally. We’re seeking a dedicated MDM Validation and Compliance Manager to implement compliant data management processes and manage audits. You’ll oversee incident and CAPA management throughout the life cycle of processes and systems. Also, you’ll maintain data integrity and managing potential risks.
It’s an excellent opportunity to contribute to our mission in a rewarding environment.

REQUIREMENTS

  • Master’s degree in Natural Sciences, Informatics, Business Administration or comparable qualification
  • Multiple years of experience in validating master data systems (MDM); ideally workflow based
  • Extensive audit management experience
  • Profound experience in Quality Assurance ideally in a pharma or in a similarly regulated environment
  • Excellent expertise in Software Validation according to Lean Validation (LEVA) ideally for master data systems
  • Good communication skills, including preparation of documentation for presentations, and intercultural experience
  • Fluency in English as well as solid German skills
Responsibilities
  • In your new role, you will manage the overall change control for GBS MDM in a lean fashion.
  • Moreover, you will compile and review the overarching documents related to validation of computerized systems and review and approve software life cycle documents.
  • As an expert in the field of validation, you will guide project and maintenance teams regarding all aspects of validation and manage periodical reviews.
  • You will act as facilitator for MDM CAPA meeting and manage incidents / deviation, investigation and CAPAs for MDM.
  • One of your main tasks, will be to prepare and manage audits or other authority inspections.
  • You will also manage GDPR compliance requirements in MDM and the quality system with Standard Operating Procedure (SOP) for MDM.
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