Senior IT Quality & Compliance Manager Job at Boehringer Ingelheim – Biberach an der Riß
At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.
In your role as Senior IT Quality & Compliance (Q&C) Manager, you will be responsible for defining and implementing IT Quality & Compliance concepts, considering the regulatory environment (GxP). You establish IT quality management processes in the global organization in order to ensure regulatory correct processes and support the different business areas in answering IT relevant questions in audits and inspections.
In doing so, you keep an eye on new trends and strategic goals in the field of computer validation (e.g. benchmarks with other pharmaceutical companies) and special requirements of new technologies (e.g. agile methods, cloud computing, data integrity).
Discover our site Biberach: xplorebiberach.com
Tasks & responsibilities
You ensure an efficient and risk-based validation approach to avoid unnecessary complexity in qualification/validation projects using risk assessments or also configuration/installation tests.
In this context, you check that all quality-relevant IT documents comply with legal and regulatory requirements, all corporate compliance instructions and the latest trends and technologies.
Furthermore, you develop concepts for the use of new technologies in the GxP environment, for the reduction of complexity and increase of efficiency of relevant IT processes under consideration of risk-based approaches.
You will work closely with the various Quality & Compliance functions of the different business units at global, regional and local level to meet their IT quality and compliance requirements.
You will independently conduct compliance trainings and consultations in the GxP and non-GxP environment to raise awareness of these topics, ensure communication within IT and continuously adapt the high quality standards within IT to the changing regulatory requirements.
Your tasks also include the coordination and support of internal and external audits and inspections.
Master’s degree in computer science with a focus on IT process governance/quality management or comparable scientific degree
Long term of professional experience in an international IT environment
Several years of experience with quality management systems (e.g. GAMP) and IT standards (e.g. ITIL)
In-depth knowledge of the regulatory environment (e.g. GxP, audits)
Deep knowledge of GxP-relevant IT processes and their support by computerized systems
Broad knowledge of IT quality and IT compliance, process governance and risk management
In-depth knowledge of technological developments on the IT market
Dealing with new methods (e.g. Agile) and technologies (e.g. Cloud Computing) in a regulated environment
Strong communication skills, analytical thinking and the ability to work in partnership
Ability to build consensus and influence decisions
Fluent in written and spoken English and German
Willingness for business trips < 20% (also on a global level)
EFFECTS OF COVID-19
We will continue to hire talented people and we look forward to receiving your applications. As a result of COVID-19, we have introduced alternative working arrangements to ensure that our employees can stay safe and healthy, because the health of our employees is among our top priorities. At all company locations, we work remotely whenever possible. Additionally, we are now hosting virtual video interviews for applicants. During the limited in-person interviews we still have during this time, we pay special attention to distance and the hygiene rules recommended by the Robert Koch Institute. New employees who do not start on site in production or the laboratories are sent the necessary IT equipment, our Welcome Days take place online, and we plan to conduct their onboarding training virtually whenever possible.
WHY BOEHRINGER INGELHEIM?
This is where you can grow, collaborate, innovate and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area.
Want to learn more about us? Visit https://www.boehringer-ingelheim.com/
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.
READY TO CONTACT US?
Please contact our Recruiting EMEA Team, Tel: +49 (0) 6132 77-173173
Not exactly the position you are looking for but have someone else in mind? Share it via the button on the bottom of the page with friends or colleagues who might be interested.
Job – Information Technology
Primary Location – Europe-DE-Baden Wuerttemberg-Biberach
Organization – DE-Boehringer Ingelheim GmbH (Germany)
Schedule – Full-time
About the Company
Company: Boehringer Ingelheim –
Company Location: Biberach an der Riß