Life Sciences Project Manager

Life Sciences Project Manager

Brussels, Belgium

We are seeking a Project Manager to oversee and execute operational tasks related to Computer

System Validation (CSV), Infrastructure Qualification, and System Lifecycle Management. This role

involves developing and maintaining digital IT solutions, ensuring adherence to regulatory standards,

and managing project and operational activities.

Responsibilities:

Documentation Management:

• Identify and prioritize necessary System and Project documentation.

• Track document status, including authoring, review, and approval timelines.

• Ensure adherence to Good Documentation Practices (GDP) and internal standards.

• Author and review System and Project documents to meet regulatory and compliance

requirements.

Project Management:

• Collaborate with Project Managers to integrate compliance and IT security activities into

project plans.

• Monitor project progress and ensure timely completion of validation and IT security tasks.

• Facilitate regular check-in meetings with Project Managers to align on timelines and

deliverables.

• Escalate critical compliance and security issues to relevant stakeholders.

Quality and Compliance:

• Work closely with Quality Managers and IT Security Representatives to embed quality and

security principles into project and operational activities.

• Review test specifications, test results, and deviations to ensure compliance.

• Contribute to project-related audits, assessments, and inspections.

Risk Management:

• Identify, assess, and mitigate project and operational risks.

• Document risks and mitigation strategies in relevant project documentation.

• Ensure compliance with risk management procedures and internal standards.

General:

• Utilise internal IT tools and adhere to company policies and procedures.

• Request necessary services, such as vendor IT security assessments, as required.

Required Skills:

• 7-10 years of experience in a relevant role

• Strong understanding of Computer System Validation (CSV) principles and practices

• Excellent project management skills

• Strong attention to detail and organizational skills

• Ability to work independently and as part of a team

• Fluency in English, with proficiency in Flemish or French

Working Environment:

• Workplace type: Hybrid (2-3 days per week onsite requirement)

• Client location: Brussels, Belgium

• Contract type: B2B