Validation Lead

Job Location :

Billennium is looking for a talented Validation Lead to join a team of 35 Validation Specialists spread around the globe, mainly Europe, North America, and Asia, working on the pharma industry projects involving validation in the field of clinical trials, safety, medical devices, integrations, ERP, and others. This position requires an Individual Contributor with a problem-solving mindset, open to working in a multicultural environment along with other stakeholders.

Your role

  • Determines validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerised systems
  • Responsible for the review of software documentation according to CSV corporate SOP's, and regulatory guidance
  • Provide estimates and forecast validation activities for a project
  • Author validation plans/reports, reviews test plans/reports (and other deliverables) to asses and notify that system is ready to go life
  • Determine testing strategy, requirements and acceptance criteria
  • Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards
  • Coordinate and advise on all validation activities on a global level/organizational level for system/project
  • Participate actively in validation discussions, provide consultancy for all validation related questions
  • Participate in system implementation and maintenance planning
  • Lead and author system and functional risk assessments
  • Verification of testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions
  • Review and collect expected CSV deliverables, records and other evidences according to plans
  • Prioritize activities in line with the project schedules, business needs and compliance requirement
  • Ensure code release to production and maintenance procedures are identified and adhered
  • Confirm initial data loading and/or data migration from other systems, are performed according to approved procedures
  • Assess changes to determine potential impact to the validated state of the computerised system
  • Support system maintenance with validated state and permanent audit readiness
  • Lead and author system periodic review according to procedure
  • Observe governance processes, escalates area for improvement
  • Support system audit/inspection preparation and execution as CSV subject matter expert
  • Assures strategic/essential oversight over validation support within department and provides support/consultancy for the team and within global organization if necessary.
  • Implements relevant framework and processes, propose and uses tools
  • Providing training and validation/quality knowledge/experience exchange support
  • Prepares recommendations for process optimization in his/her area of influence
  • Provide input and guidance for a computerized system retirement planning

Your skills & experience

  • 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
  • Experience in leading validation for projects and systems maintenance
  • Experience in authoring validation plans, reports and deliverable registries
  • Experience in authoring or reviewing validation related deliverables, records and other evidences.
  • Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical industry (or other regulated)
  • Experience in Lean and/or Agile approaches
  • Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11
  • Aware of common development technologies and governance processes impacting validation approaches
  • Ability to work collaboratively in cross-functional teams to achieve milestones and goals
  • Ability to communicate clearly and professionally both in writing and verbally
  • Ability to share knowledge and guide others
  • Ability to make sound decisions about quality and technical subjects
  • Higher education degree or relevant work experience in computer science, software engineering, information systems and/or pharma industry
  • Excellent communication skills
  • Assertiveness, conflict management skills, leadership skills
Join our team!
Join our team!

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Join our team!