Primary Job Function:

SQA Engineer supervises and provides guidance for evaluating, selecting and supporting new strategic SLC methodologies and technologies, with a main focus on compliance with regulatory expectations.

Prepares and executes IT compliance activities and/or oversees IT compliance activities.

Applies IT and compliance knowledge and experience to analyze and makes proposals to support of compliance related topics.

Leads the IT compliance activities within an area.

Core Job Responsibilities:                                                                     

Provides compliant global validation packages Works autonomously with related Global IT contacts and the business process SMEs for this purpose. Primary support to project teams as Software QA lead for the Validation of IT applications. Ensures continuous improvement and gives input related to the Validation strategy for IT changes. Supports the validation and use of IT systems for BTS Proposes and/or approves corrective/preventive actions in case of deviations and ‘out of spec’ situations for global IT systems. Gathers and analyzes data and reports on metrics for assessing effectiveness of IT compliance related processes. Provides IT validation SME on compliance regulations within an area/division/region Supportss relationships and integrates IT compliance activities with relevant BTS and divisional stakeholders to ensure successful implementation and support of IT compliance activities and or projects.

Position Accountability/Scope:

Works with minimal management direction.

Monitors and organizes the efforts of IT Compliance staff.

Minimum Education:

• Bachelors Degree in Science or equivalent in Information Technology or equivalent.

  
  
  

Minimum Experience/Training Required:

Good analytical skills and the ability to organize work in a logical, thorough and succinct manner. Good leadership skills Good knowledge of IT systems, risk management principles, regulatory requirements and industry best practices like Agile and test automation. More than 4 years in validation in health care environment and at least 2 years in working in global teams. Excellent analytical, judgment and consultative capabilities and communication skills and the ability to independent and work with both IT management and staff.