IT Compliance Consultant (Validation SME)
Company Name:
AbbVie
IT Compliance Consultant-(Validation SME)-140000022H
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.
Description
Provides guidance to the staff in software validation activities including: reviewing software requirement documents, writing and reviewing validation documents (test plans/strategy and detailed test cases/instructions), executing and reviewing validation test cases, updating departmental procedures and SDLC templates. Identifies, proposes, initiates and leads significant improvement programs related to the IT Compliance policy, processes, and procedures. Leads the IT Compliance activities within a client area, providing oversight on a project or multiple initiatives. Provides input into resource planning and allocation across multiple projects/client areas for IT Compliance activities.Ensures that documentation is in compliance with policy and procedures. Leads and provides oversight in implementation of testing methodologies and/or IT Compliance practices for the organization.
Key Job Responsibilities include:
Provides validation support for IT projects and ongoing activities, supporting existing applications.
Develops the testing strategy and architecture for large projects and develops the overall IT Compliance plans and timetables.
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.
Communicates project progress by producing project reports to provide timely and accurate status to the Project team, Division, Cross Division and Executive management. Makes recommendations based on current project status to resolve issues.
Performs work using standard methodologies, processes and tools to ensure IT Compliance.
Resolve issues that may delay multiple projects for the client area or otherwise subject the company to financial or regulatory risk.
Oversees project tasks and timelines of staff members, and is held accountable to them.
Gathers and analyzes data and reports on metrics for assessing effectiveness of IT Compliance-related processes for the division.
Develops business relationships and integrates activities with other internal 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.
Responsible for securing, on-boarding and coordinating the assignment of validation and testing resources.
Exercises considerable latitude in determining objectives of assignments.
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 needs and the information upon which the business justification and prioritization decisions are made.
Accountable for communicating the business need and drivers to development groups to assure the implementation phase can fulfill the business need.
Influences or has final decision authority for 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 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.
Develops and proposes solutions to ensure on-going compliance with industry rules and regulations (internal and external).
Influences organization decisions and business area objectives.
Decisions impact achievement of business area objectives.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Qualifications
Basic:
Bachelors Degree or equivalent certification or experience.
7-9 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 both IT management and staff
Key AbbVie Competencies:
Builds strong relationships with peers and cross functionally and with partners outside of team to enable higher performance.
Learns fast, grasps the 'essence' and can change course quickly where indicated.
Raises the bar and is never satisfied with the status quo.
Creates a learning environment, open to suggestions and experimentation for improvement.
Embraces the ideas of others, nurtures innovation and manages innovation to realty
To apply directly for this position, please go to the following link. You can contact me directly at .
Thank you
Position will be hired based on level of experience.Estimated Salary: $20 to $28 per hour based on qualifications.
AbbVie
IT Compliance Consultant-(Validation SME)-140000022H
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.
Description
Provides guidance to the staff in software validation activities including: reviewing software requirement documents, writing and reviewing validation documents (test plans/strategy and detailed test cases/instructions), executing and reviewing validation test cases, updating departmental procedures and SDLC templates. Identifies, proposes, initiates and leads significant improvement programs related to the IT Compliance policy, processes, and procedures. Leads the IT Compliance activities within a client area, providing oversight on a project or multiple initiatives. Provides input into resource planning and allocation across multiple projects/client areas for IT Compliance activities.Ensures that documentation is in compliance with policy and procedures. Leads and provides oversight in implementation of testing methodologies and/or IT Compliance practices for the organization.
Key Job Responsibilities include:
Provides validation support for IT projects and ongoing activities, supporting existing applications.
Develops the testing strategy and architecture for large projects and develops the overall IT Compliance plans and timetables.
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.
Communicates project progress by producing project reports to provide timely and accurate status to the Project team, Division, Cross Division and Executive management. Makes recommendations based on current project status to resolve issues.
Performs work using standard methodologies, processes and tools to ensure IT Compliance.
Resolve issues that may delay multiple projects for the client area or otherwise subject the company to financial or regulatory risk.
Oversees project tasks and timelines of staff members, and is held accountable to them.
Gathers and analyzes data and reports on metrics for assessing effectiveness of IT Compliance-related processes for the division.
Develops business relationships and integrates activities with other internal 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.
Responsible for securing, on-boarding and coordinating the assignment of validation and testing resources.
Exercises considerable latitude in determining objectives of assignments.
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 needs and the information upon which the business justification and prioritization decisions are made.
Accountable for communicating the business need and drivers to development groups to assure the implementation phase can fulfill the business need.
Influences or has final decision authority for 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 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.
Develops and proposes solutions to ensure on-going compliance with industry rules and regulations (internal and external).
Influences organization decisions and business area objectives.
Decisions impact achievement of business area objectives.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Qualifications
Basic:
Bachelors Degree or equivalent certification or experience.
7-9 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 both IT management and staff
Key AbbVie Competencies:
Builds strong relationships with peers and cross functionally and with partners outside of team to enable higher performance.
Learns fast, grasps the 'essence' and can change course quickly where indicated.
Raises the bar and is never satisfied with the status quo.
Creates a learning environment, open to suggestions and experimentation for improvement.
Embraces the ideas of others, nurtures innovation and manages innovation to realty
To apply directly for this position, please go to the following link. You can contact me directly at .
Thank you
Position will be hired based on level of experience.Estimated Salary: $20 to $28 per hour based on qualifications.
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