Technical Project Manager - GxP (USA/Patient Safety)

D-ploy GmbH is seeking a Technical Project Manager / Delivery Owner to lead technology project delivery in a regulated pharmaceutical environment. The role coordinates stakeholders, technical teams and vendors while ensuring projects involving GxP-validated and qualified systems meet business, regulatory and quality requirements.

Responsibilities:

• Coordinate the delivery of technical projects and initiatives within a regulated pharmaceutical environment
• Develop and maintain project plans, including timelines, milestones and key deliverables
• Coordinate with business stakeholders, technical teams and external vendors to support project delivery
• Organize and facilitate project meetings, capture action items and follow up on outstanding activities
• Identify, track and manage project risks, issues and blockers, ensuring appropriate follow-up and escalation
• Manage external technology vendors involved in SaaS solutions and systems
• Support the delivery of projects involving GxP-validated and qualified systems, ensuring alignment with applicable regulatory and quality requirements
• Collaborate with business and technical stakeholders to facilitate effective project coordination
• Maintain project documentation and communicate progress, risks and key updates to relevant stakeholders

Requirements:

• Demonstrated experience delivering projects involving GxP-validated and qualified systems
• Experience managing technical projects in regulated environments
• Strong project planning and coordination skills, including managing timelines, deliverables, risks, issues and dependencies
• Experience coordinating SaaS solutions and managing external technology vendors
• Ability to work effectively with cross-functional teams, business stakeholders and technical specialists
• Strong organizational, problem-solving, documentation and communication skills
• Ability to work independently and effectively in an international environment
• Fluency in English
• Valid criminal record extract, not older than three months, required
• Proven experience as a Technical Project Manager, IT Project Manager, Delivery Owner or in a similar role
• preferably within the pharmaceutical, biotechnology or life sciences industry
• ideally within pharmacovigilance or drug safety
• Experience working with global pharmaceutical teams and geographically distributed stakeholders
• Familiarity with computerized system validation (CSV) processes in GxP-regulated environments