Senior IT Compliance Analyst

Profile

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ****target=_blank rel=no-follow>****Follow @abbvie on ****target=_blank rel=no-follow>Twitter, ****target=_blank rel=no-follow>Facebook, ****target=_blank rel=no-follow>Instagram, ****target=_blank rel=no-follow>YouTube and ****target=_blank rel=no-follow>LinkedIn.

• 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.
• 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.
• 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.
• Interacts with functional groups at various management levels to gain cooperation, foster collaboration and influence project outcomes.
• Facilitates validation activities within the team and cross-functional groups.
• Ensures project tasks stay within project budget and/or time estimates.

Qualifications

 

Bachelor Degree 5 years of experience; Master's Degree 4 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.
• Working knowledge/Strong familiarity of 21 CFR Part 11 and Data Integrity requirements for computerized systems, General Principals of Software Validation, and Electronic Records/Signatures
• Strong compliance knowledge associated with a cGMP environment
•  Good documentation skills
• Strong communication skills
• Strong work ethic
• Flexible and adaptable to change
• Ability to work independently and in groups

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
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