Sr. IT Compliance Analyst

Company Name:
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries.

Oversees IT Compliance testing of new or modified applications/systems across multiple computing environments. Applies IT and Compliance knowledge and experience to analyze requirements against test cases, reviewing and approving test cases. Leads the IT Compliance activities within a project or multiple projects within a single client area. Prepares and approves documentation per policy and procedure to support the certification of an application/system. Primary support to project and IT staff related to SLC, validation and compliance process and procedures.

Key Responsibilities Include:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Develops the testing strategy and architecture for medium to large projects.
Participate in the development and or modification of automated test scripts.
Develops reviews and approves system documentation (test plans/strategies, other SLC documentation) in support of validation activities.
Leads the development and execution of test plans.
Communicates project progress by producing project reports to provide timely and accurate status to Project team.
Performs work using standard methodologies, processes and tools to ensure IT Compliance. Resolve issues that may delay the project or otherwise subject the company to financial or regulatory risk.
Establishes project tasks and timelines and is held accountable to them. Capture and report on IT Compliance data and metrics for assigned project tasks and identify potential process improvements.
Establish and maintain relationships with Software Quality Assurance Resources across functional areas.
Responsible for driving and leading the validation schedule and communicating expectations across functional areas.
Responsible for leading the development/review of system documentation (Test plans/strategies, schedules, estimates and other SLC documentation) in support of validation activities across functional areas.
May have indirect project budget responsibilities.
Ensures IT Compliance tasks stay within project budget and/or estimates. Assists in the establishment of regulated policies and procedures at the departmental level.
Establishes and maintains productive relationships with all levels in the Divisional IT organization, and business function.
Acts as a liaison and IT Compliance expert to assure successful implementations.
Serves as a source of information on the IT Compliance needs and regulatory environment. Works with minimal management direction.
Monitors and coordinates the IT Compliance efforts within a project.
Guides the efforts of less experienced staff.
Independently conceives and develops general approaches to the solution of systems problems which require application of basic IT compliance principles.
Errors or failure to achieve expected results may result in project delays and/or the expenditure of more resources or impact projects costs than was planned.



Bachelor's Degree or equivalent certification or experience. No advanced degree required.
4-6 years of experience in a quality systems environment, or equivalent combined work experience. Excellent analytical, judgment and consultative capabilities and communication skills and the ability to work with both IT management and staff.
Must have previous experience in a regulated environment.
Must have experience with electronic records and audit trails


Previous experience with HP Quality Center is preferred
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