Job Description

Experience required: 10-15 years

Project Delivery Manager (Validated Digital Application: MDRIFT)

We are seeking an experienced Project Delivery Manager to lead the delivery of the validated digital application MDRIFT through multiple enhancement projects within a GxP‑regulated pharmaceutical environment at Client Healthcare KGaA, Darmstadt, Germany. MDRIFT has been established as a Minimum Viable Product (MVP) and is now entering the next lifecycle phase in which additional functionality will be implemented through a series of projects.

The Project Delivery Manager is accountable for the successful delivery of the MDRIFT application workstream. While the overall project is led by the Project Manager, this role is responsible for coordinating all application‑related activities required to implement changes while maintaining the validated and qualified state of MDRIFT throughout its lifecycle.

This role is organizationally embedded within IT and partners closely with the Project Manager, Quality Assurance, Validation, Business Functions, Infrastructure, Cyber Security, Operations, Regulatory Affairs, and other stakeholders. The primary challenge is ensuring all organizational, governance, quality, validation, and operational activities required for compliant delivery are initiated, coordinated, tracked, and completed successfully.

Key Responsibilities

• Own the delivery of the MDRIFT application workstream within the overall project.
• Coordinate all activities required to deliver enhancements to the validated MDRIFT application.
• Ensure application changes are implemented in accordance with Client Healthcare KGaA’s Quality Management System (QMS), GxP requirements, the governance framework, and internal procedures.
• Coordinate cross‑functional activities involving IT, Business, Quality Assurance, Validation, Infrastructure, Cyber Security, Operations, Regulatory Affairs, and other relevant functions.
• Ensure all required Change Controls, impact assessments, validation activities, testing, documentation, reviews, approvals, and release activities for MDRIFT are completed.
• Drive execution of organizational activities and proactively follow up on outstanding actions across all participating departments.
• Identify delivery risks, organizational dependencies, and potential bottlenecks; coordinate appropriate mitigation measures.
• Maintain close alignment with the Project Manager regarding project priorities, timelines, risks, and overall delivery status.
• Provide transparent reporting on delivery progress, issues, risks, and readiness for implementation.
• Support inspection readiness by ensuring that all required documentation and evidence for MDRIFT are complete and maintained.

Reporting Relationships

• Functionally reports to the Project Manager for all project‑related activities.
• Organizationally embedded within the IT organization and reports to the respective IT line manager.
• Acts as the central coordination point for all MDRIFT delivery activities across the involved functions.

Required Qualifications

Essential

• Proven experience as a Project Delivery Manager, Project Manager, Delivery Lead, or similar role within a regulated pharmaceutical, biotechnology, or medical device environment.
• Strong understanding of GxP‑regulated computerized systems throughout their lifecycle.
• Experience with Computerized System Validation (CSV), Computer Software Assurance (CSA), Change Control, Quality Management Systems (QMS), and regulated software delivery.
• Demonstrated ability to coordinate complex cross‑functional initiatives involving multiple organizational stakeholders.
• Strong communication, organizational, planning, and stakeholder management skills.

Strongly Preferred

• Prior experience working within or supporting Client Healthcare KGaA, Darmstadt, Germany in a comparable delivery or governance role.
• Familiarity with Client Healthcare KGaA’s governance framework and organizational structure.
• Knowledge of internal QMS processes, validation, quality, release, and approval workflows.
• Understanding of Client cross‑functional collaboration models, decision‑making processes, and stakeholder landscape — enabling minimal onboarding and rapid contribution to compliant delivery.

Personal Competencies

• Excellent coordination and organizational skills.
• Leadership through influence rather than formal authority.
• Ability to build effective relationships across multiple functions.
• Structured, proactive, and solution‑oriented working style.
• Strong sense of ownership and accountability.
• High level of quality and compliance awareness.
• Ability to manage multiple priorities in a dynamic project environment.

Success Criteria
The successful Project Delivery Manager ensures that every enhancement to MDRIFT is delivered in full compliance with Client Healthcare KGaA’s governance model and applicable GxP requirements. Success is measured by timely implementation and by the ability to effectively orchestrate cross‑functional organizational activities, maintain the validated state of MDRIFT, and ensure that all required quality, validation, governance, and operational processes are completed efficiently and in line with regulatory expectations.

Future Perspective
As MDRIFT matures beyond the current project phase, Client Healthcare KGaA intends to establish a dedicated Center of Excellence (CoE) to support long‑term operation, continuous improvement, and lifecycle management within the GxP‑regulated environment. The CoE is expected to be IT‑led and partner with the Business for functional priorities. The Project Delivery Manager will play a key role in supporting the establishment and operationalization of this CoE by contributing to:

• Establishing sustainable governance and delivery processes for MDRIFT.
• Coordinating cross‑functional collaboration between Business, IT, Quality Assurance, Validation, Infrastructure, Cyber Security, and Operations.
• Supporting application lifecycle management, including change management, release management, validation, and continuous improvement.
• Developing standardized delivery and governance practices to ensure long‑term compliance and operational excellence.
• Facilitating the transition from project delivery into sustainable operational management while maintaining the validated state of MDRIFT.
• This position offers the opportunity to shape both successful delivery of the current enhancement projects and the long‑term operating model for one of Client Healthcare KGaA’s strategic digital solutions.