Global QA (e-Compliance) Manager (m/f)

REFERENZNUMMER:

268870/1

IHRE AUFGABEN:

-Responsible for providing Quality Assurance support on behalf of the business with regard to computerized systems validation (CSV), operating within a framework of regulations (GxP, 21CFR11 etc.) and requirements defined in global procedures
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-Act as the single point of contact for guidance on CSV-related topics and related information
-Review and approve relevant system lifecycle documentation related to validation and validation changes from a content/e-compliance perspective
-Approve changes and deviations, failure Investigation and CAPAs associated with GxP computer systems (operational changes according to change control process)
-Provide guidance on computerized system validation (CSV) and data integrity
-Act as the interface between the business, the IT and the QA organizations for CSV-related topics
-Report performance metrics and project status updates where relevant to Global QA (e-Compliance) Manager (Pharma QSS)
-Report potential CSV global compliance issues
-Contributes to managing, assessing and resolving GxP-critical deviations from an e-Compliance perspective

IHRE QUALIFIKATIONEN:

-Graduate in Engineering, Pharmacy, Chemistry, Natural Sciences, Information Technology or profound equivalent experience in the pharmaceutical or a related regulated industry
-Combined in-depth experience in the fileds of risk management, Quality Assurance, information security, compliance and IT
-Strong working knowledge of CSV- and e-Compliance-related systems, e.g. SAP in a GxP environment
-Expert knowledge in one of the following: GLP-, GCP- or GMP-compliance in one or more global regulatory environments (FDA, MHRA, EMA etc.)
-Working knowledge in all areas of compliance in one or more global regulatory requirements
-Ability to negotiate favorable outcomes while maintaining positive working relationship
-Skilled in risk assessment methodologies and project organization
-Fluency in English, German is of advantage
-Ability to communicate quality-, compliance-, security- and risk-related concepts to technical and non-technical audiences
-Strong organizational and IT project management skills, scheduling and resource management skills
-Familiarity with compliance requirements (e.g. FDA, EMA GMP, GLP, GCP, records management, BC/Disaster Recovery)

WEITERE QUALIFIKATIONEN:

Quality assurance professional