Sr. QA IT Audit Project Manager

Found in: Resume Library US A2 - 2 weeks ago


North Chicago Illinois, United States AbbVie Full time
Job Description

Come to work each day with an inclusive and collaborative business technology team. As a Senior IT Audit Project Manager in AbbVie Business Technology Solutions (BTS), you’ll have opportunities to contribute to the digital transformation of a leading biopharma company, helping to create solutions that impact patients and their communities for the better.

This position can be remote anywhere in the U.S.

Our Business Technology Solutions (BTS) team shapes the digital transformation accelerating the future of medicine at AbbVie—and we do it together, asking bold questions and taking on tough challenges through deep, honest collaboration. In the role of IT Supplier Audit Project Manager, you will join a diverse, global team that invests in your customized career growth and uses technology and data to positively impact people’s lives.

The function of the IT Audit Project Manager is to perform evaluations for compliance with US and foreign regulation requirements (minimally may include the Americas, Asia, Africa, Australia, European Middle East regions) and provide constructive evaluation of quality related systems for suppliers that provide services and products to AbbVie.   Suppliers can include third-party IT system and Services suppliers.   Their execution in GXP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness, and safety of our products.

Assess compliance of systems, services, facilities, and procedures per applicable regulations through audits and assessments of our GxP IT suppliers, assuring compliance to regulatory requirements and AbbVie specifications.

Provide feedback in the form of audit observations, formulate recommendations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained at the supplier.

The position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and objectivity.

Participate in strategic initiatives to improve compliance to regulatory requirements and standards.

Execution of audits and assessments assigned and manages relationships with management of auditees.

Operates independently to prepare relevant audit summaries of key issues for audits supported.

Leads coordination across multiple audit teams, including AbbVie and future acquisition audit teams to ensure consistency for scoping, audit procedures performed, documentation, reporting and issue resolution.

Executes audits and related follow-up as assigned.

Leads ad hoc analysis, projects and process improvements as needed.

May have supervisory responsibility for one or more direct reports.

 

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

 


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