Responsible for guiding the GIS Organization on requirements analysis, risk assessment, and validation/verification activities.
Coordinates the Change Management process within the GIS organization.
Reviews system changes to provide compliance assessments and closure summaries that are audit ready.
Advises project teams and internal GIS customers on validation scope, risk, and validation approach.
Assist and lead process improvement projects related to regulatory compliance within the GIS Organization.
Operate independently to manage end to end compliance activities within projects.
Develops and maintains software and hardware testing protocols (knowledge of different types of testing such as integration, unit, regression testing).
Responsible for Validation Documentation.
Participates in project and system requirements gathering/authoring; coordinates activities with business users and analysts.
Investigates root-cause of defects, failures and authors and/or investigates Non-conformances and CAPAs.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Strong oral and written skills to persuade, direct and advise stakeholders on regulatory compliance processes.
Strong organizational skills to maintain and manage multiple validation projects
Experience with enterprise applications such as SAP, LMS and EtQ.
Experience with Test Management Tools such as HP Quality Center and TFS.
Ability to articulate risk based validation strategy and provide tailored validation approach to meet the business needs.
Experience and leadership in fast-paced project implementations.
Excellent customer service and communication skills.
Experience with regulations and frameworks e.g., 21 CFR Part 820/11, ISO 13485, SOX, HIPAA and GAMP.
Experience with software development lifecycle activities, methodologies, testing and validation.
Experience with common IT infrastructure and applications, e.g., virtualization, directory services, storage, DBMS.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Typically requires a minimum of 12 years of related experience with a Bachelor's degree in Technology, Science, Business or related field; or 8 years and a Master's degree; or a PhD with 5 years experience; or equivalent experience.
Experience in Medical Devices, Pharmaceutical and/or Biotech Industries
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