Lead CQV Scheduler

Overview

The Lead CQV Scheduler is responsible for planning, developing, and managing integrated schedules for commissioning, qualification, and validation activities within life sciences projects, including pharmaceutical, biotechnology, and medical device facilities. This role ensures that all CQV activities are aligned with GMP requirements and project delivery timelines, supporting timely regulatory approval and operational readiness.

Key Responsibilities

Scheduling & Planning

• Develop and maintain detailed, resource-loaded CQV schedules for life sciences projects
• Integrate CQV schedules with engineering, procurement, construction (EPC), and manufacturing readiness plans
• Define and sequence activities for commissioning, IQ/OQ/PQ, and validation lifecycle stages
• Identify and manage critical path and near-critical activities

CQV Lifecycle Integration

• Align schedules with CQV deliverables including:
• Commissioning test protocols
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Ensure readiness for regulatory inspections and audits
• Support validation master planning timelines

Stakeholder Coordination

• Collaborate with CQV engineers, validation teams, quality assurance (QA), and project management
• Interface with vendors, contractors, and automation teams
• Lead schedule coordination meetings and milestone reviews
• Ensure cross-functional alignment across all project phases

Progress Monitoring & Reporting

• Track and report CQV progress against baseline and forecast schedules
• Develop dashboards and KPIs for CQV performance tracking
• Highlight delays, risks, and mitigation strategies to leadership
• Maintain schedule updates and version control

Risk & Compliance Management

• Identify schedule risks specific to regulated environments (e.g., documentation delays, deviations)
• Incorporate mitigation and contingency strategies
• Ensure compliance with Good Manufacturing Practice (GMP) and validation standards

Tools & Systems

• Utilize advanced scheduling tools such as Primavera P6 or MS Project
• Support integration with digital CQV and quality systems (e.g., Veeva, Kneat)
• Maintain data accuracy and scheduling governance

Qualifications

Education

• Bachelor’s degree in Engineering, Life Sciences, Project Management, or related discipline

Experience

• 8–12 years of scheduling experience within life sciences, pharmaceuticals, or biotechnology projects
• Strong experience with CQV processes in GMP-regulated environments
• Experience supporting large capital projects (greenfield or brownfield)

Skills & Competencies

• In-depth understanding of CQV lifecycle and validation processes
• Strong knowledge of GMP regulations and compliance requirements
• Advanced proficiency in Primavera P6 scheduling tools
• Excellent communication, coordination, and leadership skills
• Strong analytical and risk management capabilities
• Ability to manage multiple priorities in complex project environments

Leadership Responsibilities

• Lead CQV scheduling strategy across major capital projects
• Mentor and guide junior schedulers and planners
• Establish and standardize CQV scheduling methodologies
• Drive continuous improvement and best practices

Work Environment

• Based on-site at pharmaceutical/biotech manufacturing facilities or project offices
• May require travel to vendor sites or multiple project locations
• Hybrid working options may be available depending on project phase

Key Performance Indicators (KPIs)

• Achievement of CQV milestones (IQ/OQ/PQ completion)
• Schedule adherence and critical path management
• Accuracy of forecasting and reporting
• Inspection readiness and compliance performance
• Stakeholder alignment and communication effectiveness

Summary

The Lead CQV Scheduler in the life sciences sector plays a vital role in ensuring that commissioning and validation activities are executed in compliance with GMP standards and delivered on time. This position is critical to enabling safe, compliant, and efficient startup of pharmaceutical and biotech manufacturing facilities.