(Senior) GMP Compliance Specialist (m/f/d)

Overview

At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible. We're dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We're always striving to identify talented individuals to join our exceptional teams.

We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.

At QIAGEN, every day is an opportunity to make a real-life impact.

Join us, grow with us, and together, let's shape the future of biological discovery.

This role In this role, you support our production area with a focus on chemical and biotechnological processes and contribute significantly to ensuring safe, stable and consistent manufacturing processes. In close cooperation with production, development, quality assurance and other interfaces, you continuously develop GMP and hygiene standards and take responsibility for documentation, qualification and validation as well as the preparation and monitoring of audits. With your contributions, you promote the sustainable optimization of our processes and quality structures. Your tasks Focusing on chemical and biotechnological production processes, you support our production area in the implementation of applicable GMP regulations You first, rework and care for SOPs, manufacturing regulations, risk analysis and other GMP-relevant documents and work consistently in the Change-Control process In the case of qualification and validation activities of processes and systems, you actively participate You develop GMP, hygiene and cleaning standards, evaluate new approaches and accompany their implementation in practice Internal customer and authorities audits are ready to accompany them actively and to ensure our quality standards Your profile You have a completed scientific or engineering studies of biology, biochemistry, biotechnology or chemistry Ideally, you have already gained first experience in a regulated environment (e.g. IVD, medical devices or pharmaceutical industry) and know relevant quality standards such as ISO 13485, ISO 18385 and 21 CFR 820 Very good MS Office knowledge belong to everyday work for you; Experience with SAP, document management systems and generic AI is a welcome plus You like to work independently, but also appreciate the team's collaboration, and bring organizational talent and coordination strength with you A high level of quality, a sense of responsibility and your pronounced problem-solving competence are yours You communicate safely and addressably in German and English – both in writing and oral

What we offer

Bonus/Commission

Local benefits

Referral Program

Volunteer Day

Internal Academy (QIALearn)

Employee Assistance Program

Hybrid work (conditional to your role)

Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

See job description