The position
As of now we are seeking a dedicated and experienced Global Quality and Compliance Lead. In this strategic role, you will provide expert guidance on GxP compliance across therapeutic areas, ensuring alignment with regulatory standards and internal quality frameworks. You will support clinical development teams through risk assessments, data analysis, and inspection readiness, while contributing to global quality initiatives and continuous process improvement.
Tasks & Responsibilities
* Act as compliance expert: provide GxP guidance in the fields of EU Medical Device Regulation, EU In Vitro Diagnostic Regulation, and 21CFR aspects, as required and ensure sharing of best practices within Quality Medicine and Medicine business functions as applicable
* Support global quality issues, compliance topics and improvement initiatives
* Collaborate with clinical development teams by providing insightful trending and analysis, offering risk-based recommendations to drive continuous improvement
* Deliver training for Non-Compliance/CAPA process and other compliance topics as applicable
* Supports IDE projects (In-Depth Evaluation and Due Diligence Process) by assessing GCP compliance
Requirements
* Bachelor's or Master's degree in Medicine, Biology, Pharmacy, Business (e.g. MBA, MSc) or similar
* 7+ years' experience within pharmaceutical / CRO industry
* Demonstrated skills and knowledge of management processes in Non-Compliance and Corrective Action/Preventive Action, incl. Root Cause Analysis methodologies
* Proven experience in GxP quality management systems with strong organizational and project management skills
* Excellent communication skills in English and ability to work with people in all levels of the organization locally and internationally
* Knowledge in the fields of EU Medical Device Regulation, EU In Vitro Diagnostic Regulation, and 21CFR aspects
Please note that employment takes place via one of our external partners. The employment takes place exclusively at Boehringer Ingelheim RCV GmbH & Co KG.
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 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 Aleksandra Dawid.
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.
Our Company
Why Boehringer Ingelheim?
With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.
Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.
Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
Want to learn more? Visit https://www.boehringer-