Dutch speaking QA Manager (Remote)

Berlin

Contract

Negotiable

Quality

CR/610294_1789572106

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.

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