Dutch speaking QA Manager (Remote)
Berlin
Contract
Negotiable
Quality
CR/610294_1789572106
Dutch speaking QA Manager (Remote)
Overview
We are supporting an innovative biotech organisation as they progress their clinical development programme. Following a recent Phase I submission and an upcoming Phase II submission for a kidney disease basket study, the company is seeking an experienced German-speaking QA Manager to provide part-time quality leadership on a remote basis.
This is an excellent opportunity for a senior quality professional who enjoys working independently within a growing biotech environment and helping build scalable quality systems to support future development milestones.
Key Responsibilities
- Oversee and maintain the company's Quality Management System (QMS)
- Ensure ongoing compliance with GCP, GMP, and applicable regulatory requirements
- Lead vendor quality oversight activities, including qualification and performance monitoring
- Support inspection and audit readiness across the organisation
- Contribute to the development and implementation of a training management platform
- Review, develop, and improve quality processes, policies, and procedures
- Provide QA support for ongoing and upcoming clinical submissions
- Partner with internal and external stakeholders to ensure quality standards are maintained across clinical and operational activities
- Identify compliance risks and implement effective mitigation strategies
- Drive continuous improvement initiatives within the quality function
Requirements
- Fluent German and English
- Minimum 8-10 years of QA experience within biotech, pharmaceutical, or life sciences environments
- Strong working knowledge of GCP and GMP regulations
- Proven experience managing or maintaining QMS frameworks
- Experience with training management systems and quality documentation processes
- Vendor management and quality oversight experience
- Demonstrated success preparing organisations for inspections and audits
- Ability to work autonomously within a remote environment
Nice to Have
- Nephrology / kidney disease experience
- Ophthalmology experience
- Exposure to Phase I and Phase II clinical programmes
- Experience within emerging or venture-backed biotech companies
Ideal Candidate Profile
We are looking for a senior QA professional with at least 8-10 years of biotech or pharmaceutical quality experience who can operate independently in a part-time leadership capacity. The ideal candidate will have strong GCP and GMP expertise, extensive QMS experience, and a track record of supporting inspection readiness, vendor oversight, and quality compliance within clinical development programmes. Experience in kidney disease, nephrology, or ophthalmology would be highly advantageous. Fluency in German is essential.