Global Quality Project Manager - Regulated Pharma

Aenova Group; Starnberg; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical contract manufacturer in Ohio is seeking a Project Manager Global Quality to oversee Quality projects, including regulatory compliance and project management in a dynamic environment. The ideal candidate will have a degree in natural sciences and bilingual proficiency in German and English, along with strong project management experience. This role offers a meaningful opportunity to contribute to health outcomes while working independently and under pressure.

Qualifications

• Degree in natural sciences (e.g. pharmacy, chemistry, biology, food technology) or comparable qualification.
• Very good command of both German and English.
• Familiar with project management tools.

Responsibilities

• Manage Quality projects including Veeva implementation and LIMS.
• Planning and initiation of business cases.
• Ensure regulatory compliance with FDA or EMA.

Skills

Project management experience in regulated environment

Very good command of both German and English

Results oriented and conflict‑solving skills

Team player with very good communication skills

Education

Degree in natural sciences

Tools

Jira

Job description

Project Manager Global Quality (f/m/d)

Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you! Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Our site in Starnberg is the headquarters of the Aenova Group.

Your key responsibilities

Aim of the Corporate position is to manage Quality projects (long term projects such as Veeva implementation or LIMS, but also some smaller projects in parallel) and to ensure that the Quality Management System at Aenova meets regulatory requirements, the customer demands and the company standards.

In particular, the inbumbent is responsible for:

• Planning and initiation of business cases, definition of the project scope, objectives and deliverables. This includes gathering requirements, assessing feasibility and developing a project plan that aligns with organizational goals
• Monitoring of timelines and budget
• Managing stakeholders and Steering Committees and translating Quality business needs into IT requirements
• Ensuring regulatory compliance that the projects comply with authority regulations such as FDA or EMA
• Identifying potential risks, developing mitigation strategies and ensuring that the projects remain on track despite challenges
• Escalating any risk or issue (expected or faced) to upper management in a timely manner

Your profile

• Degree in natural sciences (e.g. pharmacy, chemistry, biology, food technology) or comparable qualification
• Approximately 5 years of project management experience in regulated environments
• Proven track record in managing multi-site and cross-regional projects
• Strong experience in managing IT-related projects and systems
• Experience collaborating with cross-functional and international teams
• Familiar with Jira or any equivalent project management tool
• GMP and CSV exposure is a plus
• Team player with very good communication skills
• Results oriented and conflict-solving skills as well as able to work under pressure independently
• Very good command of both German and English
• Willingness to travel across the Aenova sites

Your motivation

Are you looking for new challenges in a highly competitive environment? And you want to tackle them creativelyand on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions ratherthan problems? What are you waiting for? We would be happy to explain our corporate benefits in a personalconversation!

If you have any questions, I - Melanie Rümmele / Human Resources - will be happy to help you: [phone]