Job Offer GxP/CSV Quality Manager (gn)
It was founded in 2004 by Oliver Herrmann with the vision of combining process management with validation requirements for computerized systems and making them available via an integrated service portfolio. Experience from a multitude of projects of all sizes and scopes has generated a solid body of knowledge that can be leveraged to offer our clients suitable solutions for their needs.
Our client base now consists of over 160 companies, including companies in the life science industries, such as pharmaceuticals, medical technology and biotechnology, as well as their suppliers and service providers.
Through active membership in national and international associations and organizations, as well as a wide range of contacts in industry, academia and government, we are very familiar with both current standards and upcoming developments, and we provide substantial input to many of them.
This is accompanied by individual mentoring and extensive training opportunities tailored to your needs.
In return for your commitment, social skills and abilities, we offer you an attractive and inspiring working environment, as well as extensive and diverse opportunities for personal and professional development.
As a future GxP/CSV Quality Manager, you may already have experience in general QM processes, validation of computerized systems, infrastructure qualification and controlled development of software. You may already be familiar with data integrity requirements in the GxP environment and how to ensure compliance. Supporting our clients in questions concerning QM systems.
Assuming responsibility for supporting and leading validation projects at customer sites and ensuring full compliance with regulatory, internal and client requirements.
Planning and executing risk management activities (e.g. risk assessments, risk communication, action planning).
Ideally, you already have at least five years of professional experience in a regulated environment as a quality manager, validation manager, auditor or similar activities.
You are familiar with the GxP requirements of regulated industries for computerized systems validation, software development, qualification, data security and data integrity.
Your knowledge of English and German is very good.
Attractive salary package
Flexible work location within Germany (home office)
Flat organizational structures with fast decision-making processes
Individual support for your professional and personal development