Technical Project Manager - GxP (USA/Patient Safety)

D-ploy GmbH; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

D-ploy GmbH in the USA is seeking a Technical Project Manager / Delivery Owner to lead the delivery of technology projects in a highly regulated pharmaceutical environment. You will ensure alignment with business objectives, regulatory requirements and quality standards.

Ideal candidates combine strong technical project management skills with hands-on experience delivering GxP-validated systems, ideally within pharmacovigilance or drug safety, coordinating with stakeholders, vendors and

Qualifications

• Proven experience as a Technical Project Manager or Delivery Owner.
• Experience delivering GxP-validated systems in pharma.
• Experience coordinating SaaS solutions with external vendors.
• Strong planning, risk and stakeholder management.

Responsibilities

• Coordinate delivery of technical projects within a regulated pharmaceutical environment.
• Develop and maintain project plans with timelines and milestones.
• Coordinate with stakeholders, technical teams and vendors to support delivery.
• Facilitate project meetings and track action items.
• Identify and manage risks, issues and blockers with escalation.
• Support delivery of GxP-validated systems ensuring regulatory compliance.
• Maintain project documentation and communicate progress to stakeholders.

Skills

GxP experience

SaaS coordination

Regulated environments

Cross-functional collaboration

English fluency

Tools

CSV knowledge

Job description

D-ploy is a dynamic IT and Engineering Solutions company operating across the EMEA region, including Switzerland, Germany, Czech Republic, Austria, the UK, and the USA. We are committed to delivering reliable and efficient services to our clients through strong partnerships and a people-focused culture.

We are looking for an experienced Technical Project Manager / Delivery Owner to lead the delivery of technology projects within a highly regulated pharmaceutical environment, ensuring alignment with business objectives, regulatory requirements and quality standards.

This role is ideal for someone who combines strong technical project management skills with hands‑on experience delivering GxP-validated and qualified systems, ideally within pharmacovigilance or drug safety.

You will work closely with business stakeholders, technical teams and external vendors to ensure the successful planning, coordination and delivery of technology initiatives.

Key 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

What We\'re Looking For

• 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.
• Demonstrated experience delivering projects involving GxP-validated and qualified systems.
• Experience managing technical projects in regulated environments, ideally within pharmacovigilance or drug safety.
• 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.

Nice to Have

• Experience working with global pharmaceutical teams and geographically distributed stakeholders.
• Familiarity with computerized system validation (CSV) processes in GxP-regulated environments.
• Broad range of tasks and responsibilities
• Friendly and international working environment
• Referral program (“Fishing for Friends”)