Sr. IT Compliance Consultant-Validation SME

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.

Provides senior-level consultation and direction to functional areas on IT Compliance policy, process, and procedures. Identifies, proposes, initiates and leads significant improvement programs related to IT Compliance policy, processes and procedures. Leads the IT Compliance activities across multiple projects/client areas. Performs resource planning and allocation across multiple projects/client areas for IT Compliance activities. Ensures that documentation is in compliance with policy and procedures. Develops and leads the implementation of testing methodologies and/or IT Compliance practices across multiple divisions. Responsible for the interpretation and communication of systems compliance regulations within the division.
Key Responsibilities include:
Responsible for validation with applicable Corporate and Divisional Policies and procedures.
Leads IT Compliance staff in the preparation and conduct of compliance and validation testing for new or revised applications/systems at the functional business unit level.
Provides guidance to staff during review and approval of IT Compliance/validation system documentation. Coordinates portfolio of solutions offered, and identifies interdependencies.
Partners with other IT functional areas to remain current on project status, and informs customers of progress.
Performs work using standard methodologies, processes and tools to ensure IT Compliance.
Resolve issues that may delay multiple projects for multiple client areas across the division or otherwise subject the company to financial or regulatory risk.
Oversees project tasks and timelines of staff members and is held accountable to them.
Manages and provides oversight for all validation activities such as project estimation, developing testing strategies, review, and approval of IT Compliance system documentation, metrics, and status supporting.
Develops business relationships and integrates activities with internal and external IT and QA departments to ensure successful implementation and support of project efforts by ensuring consistent IT Compliance practices.
Identifies information required to support the business processes and collaborates in the development of appropriate strategies.
Indicate the reporting relationships, products, budgets, throughput, level and purpose of contacts (internal and external), or other scope measures that are key to this position.
Final decision authority for departmental and project-level budget and activities.
Assists in the establishment of regulated policies and procedures within the organization.
Establishes and maintains productive relationships with all levels in the Abbott IT organization, division business functions and with external partners.
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.
Assignments are often self-initiated.
Plans and pursues courses of action necessary to obtain desired results.
Establishes organizational objectives and delegates assignments.
Accountable for actions and decisions taken by self and subordinates.
Accountable for the accuracy of the fit of the proposed solution to the business needsand the information upon which the business justification and prioritization decisions are made.
Also accountable for communicating the business need and drivers to development groups to assure the implementation phase can fulfill the business need.
Develops and proposes solutions to ensure on-going compliance with industry rules and regulations (internal and external).
Decisions are critical to organization success.
Decisions impact achievement of business area objectives.
Significantly contributes to business process improvement and overall knowledge of the organization.
Bachelor's Degree or equivalent certification or experience.
10+ years' 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 IT management and staff.

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