Validation Project Manager

Oxford Global Resources; Galway; On-site; EUR 90,000 - 130,000; Full time

Job summary

Oxford Global Resources is seeking a Validation Program Manager – CSV in Ireland. The role oversees planning, governance, and delivery across CSV/CSA activities, coordinating validation teams, SQA, IT and process owners to ensure timely, compliant delivery.

Responsibilities span risk-based validation, change control, and certification across MES, ERP, LIMS and other GxP systems. The candidate will manage multi-team delivery pods, drive schedules, monitor dependencies, and ensure continuous

Qualifications

• Significant experience in programme or project management within CSV/CSA environments.
• Strong governance, reporting and stakeholder management skills.
• Exposure to AI-enabled systems and risk-based assurance approaches.

Responsibilities

• Own the integrated validation portfolio plan, coordinating delivery commitments.
• Oversee development and maintenance of validation plans, milestones and schedules.
• Coordinate schedules across delivery pods, validation engineers, SQA reviewers and stakeholders.
• Maintain a consolidated programme-level risk, action, issue and dependency log.
• Chair the Monthly Portfolio Review and prepare governance materials.
• Own the consolidated portfolio dashboard and monthly programme status pack.
• Maintain oversight of validation plans and ensure compliance with GxP requirements.

Skills

Programme management

CSV validation

CSA

GxP knowledge

Job description

Job Specification: Validation Program Manager – CSV

Location: Ireland

Function: Computer System Validation & Lifecycle Delivery Services

Role Overview

The Validation Program Manager will be responsible for the overall planning, coordination, governance and delivery oversight of a portfolio of Computer System Validation (CSV) and Computer Software Assurance (CSA) activities across GxP-regulated systems.

Operating across multiple validation workstreams or delivery pods, the Program Manager will ensure that projects are appropriately prioritised, resourced, scheduled and delivered in accordance with agreed timelines, quality standards and regulatory requirements.

The role will act as the operational lead for the programme, coordinating validation teams, System Quality Assurance (SQA), business stakeholders, IT and system owners to manage dependencies, resolve delivery constraints and maintain portfolio-level visibility.

The programme will encompass risk-based validation across traditional GxP systems, CSA approaches and AI-enabled systems, covering the full lifecycle from planning and test execution through change control, closure and ongoing compliance.

Key Responsibilities

1. Portfolio Planning and Resource Management

• Own the integrated validation portfolio plan, coordinating project intake, prioritisation, sequencing and delivery commitments.
• Assess incoming validation demand against business priorities, regulatory commitments, available capacity and delivery timelines.
• Coordinate resource allocation across validation teams and delivery pods, identifying capacity constraints and competing priorities.
• Maintain an integrated portfolio schedule, ensuring alignment across projects, stakeholders and system availability.

2. Validation Planning and Lifecycle Oversight

• Oversee the development and maintenance of validation plans, milestones, schedules and delivery forecasts.
• Track progress across the validation lifecycle, from initial planning and risk assessment through requirements definition, testing, review, approval and closure.
• Monitor the timely completion of validation deliverables, ensuring dependencies and milestones remain aligned with programme commitments.
• Coordinate manual testing strategy and execution schedules, including preparation, test execution windows, dry runs, defect resolution and retesting.
• Oversee progress through change control and closure activities, ensuring outstanding actions and documentation are tracked to completion.
• Ensure delivery plans reflect the appropriate risk-based CSV/CSA approach and applicable quality requirements.

3. Cross-Functional Scheduling and Dependency Management

• Coordinate schedules across delivery pods, validation engineers, testers, SQA reviewers, system owners and business stakeholders.
• Manage dependencies relating to integrated system availability, test environments, test data, business-user availability and approval workflows.
• Coordinate dry-run windows, formal execution slots and SQA review queues to maximise delivery efficiency.
• Identify scheduling conflicts, bottlenecks and potential delays, implementing mitigation plans where required.
• Facilitate alignment between technical teams and business stakeholders to maintain delivery momentum.

4. Programme Risk, Issue and Escalation Management

• Maintain a consolidated programme-level risk, action, issue and dependency log.
• Identify emerging risks to timelines, validation quality, compliance commitments and resource availability.
• Coordinate risk mitigation plans, issue resolution and escalation to programme leadership or the steering committee.
• Monitor dependencies involving deviations, defects, CAPAs, change controls and documentation approvals where these affect programme delivery.
• Support informed decision-making by providing clear visibility of delivery risks, impacts and proposed mitigations.

5. Governance and Stakeholder Management

• Chair the Monthly Portfolio Review, ensuring consistent reporting on progress, priorities, capacity, risks and key decisions.
• Act as secretary to the Programme Steering Committee, preparing agendas, consolidating inputs, recording decisions and tracking actions.
• Establish and maintain programme governance routines, delivery checkpoints and escalation pathways.
• Coordinate communication across CSV/CSA teams, SQA, IT, Quality, business process owners and senior stakeholders.
• Ensure programme decisions, actions and changes to delivery commitments are documented and communicated effectively.

6. Reporting and Performance Management

• Own the consolidated portfolio dashboard and monthly programme status pack.
• Prepare quarterly business review (QBR) materials covering delivery performance, milestones, capacity, risks, resource utilisation and key achievements.
• Track programme KPIs, including milestone adherence, schedule variance, testing progress, review turnaround times, outstanding issues and closure performance.
• Provide forward-looking forecasts and highlight potential impacts on delivery commitments.
• Ensure reporting is accurate, consistent and supports timely management decisions.

7. Quality, Compliance and Continuous Improvement

• Maintain oversight of programme delivery against approved validation plans, quality processes and applicable GxP requirements.
• Work with CSV/CSA leads and SQA to ensure appropriate review and approval checkpoints are incorporated into delivery schedules.
• Support consistent application of risk-based validation methodologies across the portfolio.
• Identify opportunities to improve standardised templates, reporting, scheduling, resource utilisation and delivery processes.
• Support audit and inspection readiness by ensuring programme-level records, decisions, actions and status reporting are maintained appropriately.

Required Experience and Qualifications

• Significant experience in programme or project management within CSV, CSA, software validation in a regulated life sciences environment.
• Demonstrable experience coordinating multiple projects, workstreams or delivery teams within a complex portfolio.
• Strong understanding of the GxP computerized system validation lifecycle and risk-based validation principles.
• Experience managing validation schedules, resource capacity, dependencies, risks, issues and delivery milestones.
• Familiarity with validation documentation, manual testing, test execution, deviations, change control and validation closure.
• Experience working with Quality Assurance/SQA, IT, system owners, business stakeholders and technical validation teams.
• Strong governance, reporting and stakeholder management skills, including preparation of dashboards, steering committee packs and management reviews.
• Excellent organisational, communication, facilitation and problem-solving skills.
• Experience applying GAMP 5 and Computer Software Assurance (CSA) principles.
• Exposure to AI-enabled systems and risk-based assurance approaches.
• Experience managing validation across enterprise systems such as MES, ERP, LIMS, QMS or other GxP applications.
• Familiarity with regulated change management, audit readiness and inspection support.
• Experience managing distributed teams or multiple delivery pods.

Key Success Measures

• Delivery milestones achieved in line with agreed portfolio commitments.
• Effective resource allocation and reduced scheduling conflicts.
• Improved visibility of programme risks, dependencies and capacity constraints.
• Timely completion of testing, SQA reviews and validation documentation.
• Consistent and accurate portfolio reporting and governance.
• Successful closure of validation projects in accordance with approved plans and quality requirements.

12 MONTHS FIXED TERM CONTRACT WITH AN EXTENSION