Head of Regulatory Affairs RCV 1120 Meidling
Job ID 22345 Job Level Leadership Functional area Medicine / regulatory affairs Schedule Full-time Our Company 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.
The position As of now we are seeking an experienced Head of Quality Medicine at our Regional Center Vienna (RCV). The focus of the position is to lead and drive Quality Excellence throughout the evidence generation lifecycle – from clinical development to medical affairs, to maximize patient safety, data integrity, fast and efficient market authorizations & maintenance and enhance clinical adoption. Within this position you are partnering and guiding across all Medicine functions to lead quality excellence and culture.
Tasks & responsibilities Accountable for shaping the Medicine Quality Management System (QMS) development, implementation and ongoing maintenance and oversight
Lead and manage the Quality Medicine team; responsible for the organizational structure, and appropriate resource and budget planning
Responsible for identifying real and potential risks associated with all aspects of the QMS and proposing and implementing solutions to these fundamental and strategically relevant risks
Responsible for the Quality Management review; lead the identification and proactive communication of relevant QMS topics in order to ensure global oversight of quality topics and continuously improve the global quality management system for Boehringer Ingelheim Medicine
Responsible for Quality and Compliance technical expertise, foster cross functional and divisional quality discussions (e.g. with Healthcare compliance, Commercial Quality, etc.) to identify synergies and optimize the global BI quality management system
Requirements University degree (Master´s or comparable degree) in a scientific discipline e.g. Pharmacology or other life science
Expert in ICH GcP and applicable regulations, current knowledge in applicable GxP regulatory processes and procedures with ability to assess the impact of these processes
An experience in participating in regulatory authority inspections and interacting with Regulatory authorities is a benefit
Experience in working within a highly matrix organization and in leading teams
Demonstrated experience with design, implementation, and management of Quality Management Systems
Your Benefits Flexible working time models : home office and flexible working hours, depending on department and position – many things are possible with us
Additional days off (“bridge-days”) : more free time through additional days off to bridge single working days between bank holidays and the weekend – without having to use vacation days
Canteen & Cafeteria : whether it's coffee and croissant for breakfast, various lunch menus or snacks in between – our subsidized staff restaurant & cafeteria has something for every taste including vegetarian and vegan options
Learning & development : diverse training and development opportunities for your personal and professional growth. Because: you never stop learning
Health promotion : health is important to us – that's why we offer different programs to promote physical and mental health
Public transport ticket : we encourage our employees to use public transport on their daily way to work. Costs for public transport? We cover them!
The remuneration for this position starts at EUR 150.000 gross annual target salary per year (full time). The actual salary package depends on professional experience and qualifications. We will be happy to discuss further details in person.
We are looking forward to receiving your application online! By uploading your application documents via our application portal, we can treat your data confidentially and in compliance with the GDPR.
Do you have any additional questions about the position? Your HR Recruiting Manager for this position is Katrin Spögler.
On our career site you will find further information about Boehringer Ingelheim as an employer as well as information about the application process and our different departments.
Would you like to know what makes our employees special? What they tell about their motivation and their everyday work? Watch this video and hear for yourself what our colleagues have to share.
Apply Now