Sr. Manager Computer Systems Validation

Sr. Manager Computer Systems Validation

The Opportunity:

We are seeking a seasoned IT/Quality Assurance professional with expertise in the life sciences industry to join our team as Senior Manager, Computer System Validation (CSV). In this role, you will be responsible for ensuring the compliance and validation of GxP-relevant computerized systems supporting pharmaceutical and biopharmaceutical operations. As a key member of the IS Quality team, you will lead CSV activities across regulated and business-critical enterprise systems. This includes hands-on development and execution of risk-based validation strategies, authoring and reviewing validation documentation, and ensuring adherence to regulatory requirements and industry best practices. This position serves as a strategic liaison between Information Sciences (IS), Quality Assurance (QA), and functional business teams, supporting system implementation and change initiatives to ensure inspection readiness and ongoing compliance. The Senior Manager, CSV will report directly to the Director, IS Quality.

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  Partner with IS, QA and external vendors in the validation and delivery of new GxP computerized systems and manage change control activities for existing validated systems.
  
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  Provide direct support for the Computer System Validation (CSV) program, including the development of System Change Requests, System Risk Classifications, ERES Assessments, User Requirement Specifications, Functional Specifications, Configuration Specifications, Validation Plans, Risk Assessments, Test Protocols and Reports, Traceability Matrices, Data Migration Plans, and other validation execution deliverables.
  
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  Review and audit of computer system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements.
  
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  Collaborate with System/Business Owners and Quality to assess and classify computerized systems for regulatory impact (GxP, SOX, HIPAA, Privacy, PCI).
  
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  Ensure the execution of data integrity assessments and partner with IS, Business Owners and Quality for effective controls.
  
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  Author and revise CSV procedures, forms, and templates for continuous improvement.
  
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  Own CSV-related deviations and CAPAs, managing remediation efforts.
  
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  Ensure GxP computerized systems remain in a validated state and inspection ready.
  
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  Maintain the computerized system inventory.
  
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  Facilitate Periodic Reviews for systems and perform Audit Trail reviews.
  
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  Support GxP computer system audits and ensure qualification of computer system vendors.
  

Required Skills, Experience and Education:

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  Minimum bachelor’s degree in engineering or life science related field.
  
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  Minimum 10 years in GXP computer system validation experience in the pharmaceutical/ biopharma space.
  
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  Extensive knowledge of GxP regulations, CSV/CSA principles, 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity concepts and controls for computerized systems.
  
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  In-depth knowledge of GAMP 5, software development, lifecycle methodologies and current industry best practices.
  
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  Must have broad GxP electronic system experience preferably in a Bio-pharma sponsor organization.
  
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  Maintains awareness of current and upcoming FDA Computer Software Assurance (CSA) principles.
  
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  Familiarity with Quality, Regulatory, and Clinical Data Management platforms such as Veeva, TraceLink, Trial Interactive, Medidata, etc.
  
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  Experience with electronic signature and document management systems i.e., DocuSign Part 11, Veeva QualityDocs, Egnyte GXP.
  
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  Understanding of CSV expectations for cloud-based/SaaS systems.
  
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  Ability to lead and manage multiple CSV projects for complex computer systems.
  
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  Experience supporting regulatory inspections and audits.
  
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  Experience working with all levels of management and consulting with key business stakeholders. An ability to influence greater outcomes.
  

Preferred Skills:

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  Results-oriented with the capacity to execute projects with minimal supervision.
  
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  Possess strong written and verbal communication skills.
  
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  Attention to detail and quality.
  
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  Knowledge of IT security frameworks such as NIST, ISO/IEC 27001, SOC 2 a plus.
  
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  Familiarity with privacy regulations such as GDPR, CCPA, HIPAA a plus.