Abbott - Senior IT Compliance Analyst - Quality Assurance

Description :

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.

Responsibilities :

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

- Supports 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.