Project Management

ID1068

PM and Coordinator with Experience in Regulatory Environments

GBE, DTU Diploma
Available for: Part-time, full-time, tasks

Contact us for full CV

Competences

  • Project Management
  • Planning and Coordinating in Complex Settings
  • Creating Overview of Complex Flow
  • Stakeholder Management
  • Process Mapping and Optimization
  • Team Leadership & Development
  • Resource Planning
  • Communication & Reporting
  • Vendor Management
  • Workshop Facilitation
  • Cross-Functional Collaboration
  • Systematic Problem Solving

Key results

11 years of experience, 7 of them in medico and pharma industry, with expertise in project management, coordination, regulatory compliance, and process optimization.

  • PM for Washer on Filling Line: Restarted stalled PQ validation, established a team, and completed the process after 2+ years of delay.
  • Coordinator: Mock-up workshop Facilitator for greenfield project
  • Coordinator for FAT Validation on Multivendor Packaging Machine: Coordinated and oversaw commissioning activities and FAT validation for a 5-vendor packaging line.
  • Developed Resource Planning Tool: Created an Excel tool to enhance decision-making and efficiency across 12 CAPEX projects.
  • QA Analyst: Developed a systematic approach to close 32.000 complaints in backlog, ensuring regulatory compliance.
  • Innovation Consultant: Led the implementation of an innovation program and managed 23 innovation projects as Portfolio Manager.

Software/Standards

  • MS Office/Project
  • SAP
  • ISO 13485 (Quality management system standard for medical devices)
  • Good Manufacturing Practices
  • FDA Regulations
  • Prince2

Personal Characteristics

She is results-driven and highly adaptable, able to quickly adjust to new roles, industries, and challenges while maintaining a high level of performance.

With a proactive approach, she identifies opportunities for improvement and addresses potential issues.

She thrives in collaborative environments, building strong relationships with stakeholders and vendors to ensure project success.

She is a strong communicator, and excels in leadership, motivating teams and fostering a positive, productive environment.

Contact

Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com