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Johnson & Johnson Loopbaan

Johnson & Johnson Technology Quality Lead

Beerse, België
IT-Compliance


Vacatureomschrijving

Requisition ID: 1905719138W

The Johnson & Johnson Technology Quality (JJTQ) Lead is a member of the JJTQ organization who is responsible for ensuring Johnson & Johnson Technology (JJT) assets comply with all applicable health authority regulations and adhere to J&J policies and procedures.  Provides day-to-day operational support for Change Control, Configuration Management, and IQ/OQ in support of end-to end quality.

  • Review and approval of Change Controls. 
  • IQ/OQ review and approval.
  • Provide Quality support and guidance to the Configuration Management team for GxP applications and the supporting infrastructure configuration items within the CMDB. 
  • Support Johnson & Johnson Regulatory Compliance (JJRC) and JJT during audits
  • Partner with JJTQ and JJT to improve quality system operational efficiency, support continuous improvement initiatives and enable technology innovation. 
  • Complete or support the completion of CAPAs and Nonconformances.
  • Ensure timely escalation of quality-related issues.


Kwalificaties
Education:    
  • Bachelor’s degree in Engineering, Scientific, Technical, or Quality discipline (or equivalent education/experience).  Advanced degree preferred.
Experience
  • 5+ years of experience in a regulated environment is required 
  • 2+ years of experience with IT Systems (e.g.  SAP platforms, servers, databases, networks, infrastructure tools) in a regulated environment
  • Experience with Configuration Management processes
  • Experience with analyzing data to drive actionable activities
  • Working knowledge of change control and document management systems.  IRIS and EDMS preferred.
 
 Knowledge, Skills and Abilities: 
  • Requires knowledge of GxP and ITIL.  Excellent communication (verbal and written), leadership, influencing, negotiating, and collaboration skills.  Must be able to work independently or within a team and manage multiple projects simultaneously.  Must have proven track record resolving complex quality issues and delivering on business goals and objectives. Requires change control and qualification experience with in a regulated environment.  Must have strong data reporting and analytical skills with problem solving capabilities with attention to accuracy and details.  Can create, analyze, graph, and present data in a manner that facilitates and drives decision making.  


Primaire locatie
België-Antwerpen-Beerse-
Organisatie
Janssen Pharmaceutica N.V. (7555)
Functie
IT-Compliance
Requisition ID
1905719138W