Johnson & Johnson Technology Quality Lead
Locations: Beerse, Belgium
Functions: IT Compliance
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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.
* Bachelor's degree in Engineering, Scientific, Technical, or Quality discipline (or equivalent education/experience). Advanced degree preferred.
* 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.
Janssen Pharmaceutica N.V. (7555)