IT / OT Program Manager in GMP-Regulated Environment Mostly Remote Wanted

Project overview

Your contact person for this request

Kirsten Schmidt-Horst

Tel.: [contact removed]

E-Mail: [contact removed]

When using the male form of the word "Consultant / Developer etc.", all gender forms female/male/diverse are meant

This request may not be published on public portals

With this request, we are looking for an IT / OT Program Manager in a GMP-regulated environment

Description

We are currently looking for an IT / OT Program Manager in a GMP-regulated environment (m/f/d) for our partner's client:

Must-haves:

• Experience in project management of IT and OT projects in a regulated environment
• Experience in the pharmaceutical, biotechnological, or manufacturing environment
• Very good knowledge of stakeholder and project governance structures
• Experience in coordinating external service providers and international project participants
• Experience with manufacturing systems, infrastructure projects, or connected production systems
• Very good English skills
• Experience in Computer System Validation (CSV)
• Knowledge in GMP-regulated environments
• Experience with Inspection Readiness activities
• Experience at IT/OT interfaces in production environments
• Project experience with global IT structures

Responsibilities

Project language: English/German

Utilization: approx. 3 - 4 days per week

Fee: approx. €110.00 per hour

Payment term:

30 days

Other

• Support for ongoing IT and OT infrastructure initiatives
• Participation in the coordination of the CSV project in the area of manufacturing systems, laboratory systems, and connected production equipment
• Support in the creation and maintenance of integrated project plans, milestones, and dependencies
• Project-based coordination of collaboration between Global IT, Operations, Engineering, Quality, and external partners
• Participation in the optimization of project governance, reporting, and risk management processes
• Support in tracking risks, decisions, open points, and project dependencies
• Assistance in preparing steering committee documents and status reports
• Support in coordination with external service providers in the areas of automation and validation
• Participation in inspection preparation activities in regulated system environments
• Project-based promotion of communication between local and global project participants
• Support for knowledge transfer and transformation activities within ongoing projects

Project details

asap

Duration / End

3 months + option

remote, sometimes Frankfurt

If you can support us in this matter, please send us suitable profiles.

Please remember that we need the CV as a Word file.

Furthermore, please be so kind as to state your fee or confirm the fee requirement.

Start / End

Languages

German

Utilization

approx. 3 - 4 days per week

Payment term

30 days

Fee

approx. €110.00 per hour

Other

If you can submit a qualified offer for this request, please send us a meaningful profile, including a concrete statement on availability and conditions. Please note that we will use the data you provide exclusively for the purpose of mediating project assignments in accordance with §5 BDSG. Disclosure to third parties within this scope will only occur after obtaining your consent. Thank you in advance for your support.

• Start: asap
• Duration: 3 Monate + Option
• Remote: hybrid
• Location: remote, mal nach Frankfurt, DE
• Rate: 110-110 EUR/h
• Languages: German