Project Manager for Computer System Validation (CSV)

Project Management, PM, Computer System Validation, Computer Software Validation, CSV, GMP or GxP or FDA
Full Time, f
$120-150K + 20% bon
Telecommuting not available Travel not required

Job Description

Please note I have direct access to the Hiring Director on this position.

An International, successful, extremely profitable and the largest global privately held medical software/hardware Company is looking for a Project Manager of Software Validation. The company is privately held, has been in business for 65+ years, has $1+ Billion in revenue, has 5K+ employees, is extremely profitable and has never laid-off an employee.

The Project Manager of Software Validation will have overall responsibility for the delivery of Computer System Validation (CSV) services to ensure compliance with regulatory agencies i.e. GMP, GxP, FDA etc.

NOTE: The Project Manager of Software Validation will NOT be performing the actual validation of medical devices or medical software. The Project Manager of Software Validation will ensure delivery and compliance of all software involved in the Quality Assurance Validation process. Experience performing medical device or software validation is NOT mandatory but would be a plus in this role.

  The Project Manager of Computer Software Validation will:

  • Be responsible for performing a review of all software required and involved in the Quality Assurance Validation process (i.e. all non-medical software)
  • Review, for completeness, all Computer System Validation (CSV) deliverables (prepared by QA Validation Analysts), to ensure compliance with 21CFR Part 11, GMP, GxP and FDA Regulations; including Validation Plan and Protocol, Installation Qualification (IQ) Specifications, Operation Qualification (OQ) Specifications and Performance Qualification Specification (PQ)
  • Review all SOPs for all the computerized systems (NOT medical hardware/software) to make them compliant with 21CFR Part 11 Rules and updated all the existing procedures,
  • Follow the Standard Operating Procedure SOPs of the company in documenting Test Plan, Test Cases and Test Procedure using Business requirements and Functional requirements of the systems
  • Assess the company’s current Computer System Validation (CSV) status preceding an internal audit and review pre-and post-market summary reports to ensure compliance with FDA regulations.
  • Manage company’s Electronic Document Management Systems (EDMS), ensuring classification of records and implementation of access controls of project workspaces, adhering to company’s Group Records Management policy.
  • Serve as the point of contact for document control functions on day-to-day activities, assist in the planning, development and implementation of the business’ overall document management program to include records management and drawing/document control.
  • Manage 15 CSV deliverable projects concurrently
  • Perform all standard Project Management responsibilities including creation and maintenance of Project Plans, Project Schedules, Project Costs, Status Reports and reporting to management utilizing PM tools such as MS SharePoint, Excel and/or Visio.

Currently, the company utilizes SAP, OpenText EIM (Enterprise Information Management) Software, MS Excel and Learning Management Software to complete the QA Validation process.

The company offers full benefits (PPO & HMO) including dental and vision, matching 401K, 3 weeks of vacation, paid sick days, Short and Long-Term Disability, Life Insurance, Tuition reimbursement, casual dress and flexible work hours that all start upon employment.

Requirements:

  • MUST have experience performing and managing Computer System Validation (CSV) deliverables (prepared by QA Validation Analysts), to ensure compliance with 21CFR Part 11, GMP, GxP and FDA Regulations. NOTE: The Project Manager of Software Validation will ensure delivery and compliance of all software involved in the Quality Assurance Validation process. Experience performing medical device or software validation is NOT mandatory but would be a plus in this role.
  • Previous experience writing and executing CSV forms and protocols for GMP Systems and Software
  • Experience with and knowledge of Validation Plans and Protocols, Installation Qualification (IQ) Specifications, Operation Qualification (OQ) Specifications and Performance Qualification Specification (PQ)
  • Experience working with stakeholders and QA Validation Analysts in obtaining all software required and involved in the Quality Assurance Validation process.

The following are only a Plus (NOT MANDATORY):

  • Experience creating and delivering CSV for medical devices and/or medical hardware would be a plus
  • Any experience delivering CSV for SAP, Excel, OpenText, LMS and/or EDMS software would be a plus
  • Any experience in a GMP/Validation discipline with a knowledge and understanding of
  • Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations
  • Experience with Risk-Based Approach to Validation and Qualification
  • Experience utilizing MS SharePoint, Visio or Excel to manage projects is a plus
  • PMP certification a plus BS in CS or related degree or relevant certifications

Posted By

Al Karaptian

Hermosa Beach, CA, 90254

Dice Id : equest
Position Id : 210
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