Job ID

EMEA05019

Country

Germany

Location(s)

Hilden

Department

QA / QC / Regulatory Affairs

Employment Type

Regular Full-Time

Overview

At the heart of QIAGEN’s business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees – around 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic, international and diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day.

Position Description

You will be part of our global Computer System Validation (CSV) team to ensure that computerized systems meet compliance requirements in our GxP-regulated environment.

As Manager QA - Computer System Validation, you will be the point of contact in cross-functional teams to represent the global validation strategy for computerized systems across the software development lifecycle (SDLC).

Key responsibilities:

-Manage and support all validation activities for IT systems and applications to ensure GxP compliance according to global regulations such as 21 CFR Part 820 and Part 11, ISO 13485, Annex 11, and GAMP 5.

-Design and improve the global validation process more efficiently by implementing agile automated validation tools and AI components within the framework of GxP compliance and other relevant regulatory requirements.

-Identify and implement regulatory changes or digital improvements for the continuous effective development of the CSV process and CSV tools.

-Conduct risk assessments in individual business processes to minimize validation effort and ensure data integrity and compliance with regulatory standards.

-Create and maintain validation protocols, reports and traceability matrixes according to our global SOPs and guidelines within our quality management system.

-Ensuring the audit readiness of IT systems and applications and presenting and justifying the GxP-compliant validation of computerized systems in internal and external audits.

-Work closely with Business, IT, Quality Assurance to align validation processes and tools.

-Provide training and guidance on validation best practices and regulatory requirements.

-This role do not include people management.

Position Requirements

-University degree in Computer Science, Engineering, nature sciences or technical fields.

-5 - 8 years of experience in a CSV position in GxP regulated industries

-Good understanding in global regulations such as 21 CFR Part 820 and Part 11, ISO 13485, Annex 11, and GAMP 5.

-Experience in Data Integrity, Data Migration, Periodic Reviews, Risk Management, Change Management, and Access Management.

-Good knowledge of agile validation tools and automation test management.

-Basic understanding of Generative AI principles, process and it’s use in software development lifecycle.

-Experience in GxP compliance with global systems such as SAP S/4HANA, Siemens MES and Polarion, Salesforce (SFDC), Trackwise Digital, ServiceNow, MasterControl as well as fluent using of Microsoft Office tools.

-Solution-oriented mindset as well as the ability to deal with conflicts, assertiveness and to work independently and as part of the team.

-Strong communication skills across different departments and hierarchies in fluent English, German would be an advantage.

What we offer

At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

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.