CSV Project Manager

Lehigh Technical in East Elmhurst, NY

  • Industry: Information Technology - Project And Product Manager
  • Type: Full Time
position filled
Job Description

Role Summary:



The Computer Systems Validation (CSV) project manager reports to the Executive Director of QA Testing and is accountable for managing project teams ensuring that GxP regulated computer systems requiring retrospective and prospective CSV are validated by following regulatory requirements and companies policy and procedures.



Essential Responsibilities:



  • Provide project management oversight of external CSV contractors and company subject matter experts (SMEs) participating in CSV projects ensuring that multiple CSV teams adhere to company CSV requirements.

  • Track and provide a weekly status report on tasks, timelines, and resources necessary to meet department objectives and keeps projects within cost, scope, schedule, and resource requirements.

  • Maintain the catalog of GxP relevant software systems and the collection and storage of validation documentation.

  • May perform supplemental research to provide options for compliant solutions to barriers encountered during validation activities.

  • Work with Data Integrity IT resources and external CSV contractors to ensure that data integrity principles are considered during the requirements and design phase of new projects.

  • Participate in data integrity and data governance forums and meetings to understand company CSV and DI requirements.


Qualifications/Requirements:



  • 3 years of experience as a validation or qualification project manager in a GxP environment.

  • Experience managing multiple complex projects with teams of 10 or more.

  • Relevant technical degree

  • Actively maintain competence through participation in relevant industry working groups.


Desired Characteristics:



  • Substantial experience in the validation and/or qualification of computer systems in a GxP environment.

  • Demonstrable experience and knowledge of cGMP, GAMP5, 21 CFR Part 11 and EU GMP Annex 11 requirements

  • Excellent organizational, presentation, and meeting facilitation skills.

  • Demonstrated ability to work collaboratively and cross-functionally.

  • Excellent verbal and written communication skills.

  • Proven ability to work successfully with global teams, both remote and face to face.


Nesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.



Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

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