Project Manager

About Inova Consulting SA

Inova Consulting is an engineering consulting company specialized in the pharmaceutical and life sciences industries. We support our clients on high value-added topics, including:

• Process engineering
• Compliance and quality (GxP)
• Industrial automation and digitalization

In parallel, Inova develops innovative solutions based on artificial intelligence for the pharmaceutical sector, including:

• Transformation of quality systems (QMS)
• Automation and generation of compliance documentation
• Digital tools to improve operational efficiency

With a team of 50 employees in Switzerland and offices in Lausanne and Basel, Inova is experiencing strong growth and aims to further strengthen its presence in the market.

The Role

We are looking for a Project Manager to lead the execution phase of an Electronic Batch Record (eBR) digitalization project, focusing on software development, Computer System Validation (CSV) and deployment management.

The Project Manager will play a critical role in ensuring alignment, coordination, and successful delivery, bridging technical development, validation requirements and operational adoption.

This role requires a strong understanding of GxP environments, digital system implementation, and cross-functional coordination.

Key Responsibilities

1. Project Execution & Delivery

• Lead the execution of the eBR implementation project from development through deployment and hypercare
• Define and manage the detailed project plan, milestones, deliverables, and dependencies
• Ensure alignment between scope, timelines, and available resources
• Monitor project progress and proactively manage risks and issues

2. Cross-functional Coordination

• Coordinate all project stakeholders, including:
  • Software developers
  • CSV engineers
  • QA/Compliance teams
  • Production and end users
• Facilitate communication between technical and business teams
• Ensure consistent understanding of requirements and priorities across all parties

3. URS Clarification & Scope Management

• Review and challenge client-provided URS for completeness, clarity, and testability
• Identify gaps, ambiguities, or inconsistencies and drive resolution with stakeholders
• Manage scope evolution and change requests in a controlled and documented manner

4. Development Oversight

• Oversee software development activities in collaboration with the technical team
• Ensure that development aligns with:
  • Defined requirements
  • GxP expectations (data integrity, traceability, security)
• Support prioritization and backlog management in an agile context

5. CSV Strategy & Execution

• Coordinate the definition and execution of the Computer System Validation (CSV) strategy
• Ensure consistency between URS, functional specifications, and test documentation
• Oversee:
  • Risk assessments
  • Traceability matrix
  • IQ/OQ/PQ preparation and execution
• Manage deviations, test results, and remediation actions

6. Deployment & Go-live Preparation

• Plan and coordinate system deployment across environments (DEV / TEST / UAT / PROD)
• Organize and supervise pilot runs and dry runs (paper vs eBR if applicable)
• Ensure system readiness for go-live from both technical and operational perspectives

7. Change Management & Training

• Support the definition and execution of change management activities
• Coordinate user training sessions (operators, QA, supervisors, admins)
• Ensure user adoption and readiness for the new system

8. Hypercare & Post Go-live Support

• Lead post go-live support (hypercare phase)
• Monitor system usage, issues, and user feedback
• Coordinate resolution of incidents and continuous improvements

Required Qualifications

• Proven experience as Project Manager in pharmaceutical or other regulated industries
• Strong experience in IT project delivery, preferably in digital manufacturing or quality systems
• Good understanding of:
  • GxP / GMP requirements
  • Computer System Validation (CSV)
  • Data integrity principles (ALCOA+)
• Experience in cross-functional project coordination (IT, QA, operations)
• Ability to manage complex stakeholder environments

Technical & Functional Skills

• Familiarity with eBR / MES / digital batch record systems is a strong advantage
• Understanding of:
  • Audit trails
  • Electronic signatures
  • Role-based access control
• Experience with agile or hybrid project methodologies
• Ability to read and understand technical architecture and system design