Global Quality and Compliance Lead (m/f/d) Early Clinical Development and Medical Devices
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 (e.g. GCP, 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
* GCP knowledge
Your Benefits
* Flexible working time models: home office and flexible working hours, depending on department and position
* Additional days off (“bridge-days”): more free time through additional days off to bridge single working days between bank holidays and the weekend
* Canteen & Cafeteria: whether it's coffee and croissant for breakfast, various lunch menus or snacks in between
* Learning & development: diverse training and development opportunities for your personal and professional growth
* 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
The remuneration for this position starts at EUR 74.000 gross annual target salary per year (full time). The actual salary package depends on professional experience and qualifications.
Boehringer Ingelheim is an equal opportunities employer and welcomes applications from all sections of the community. We are committed to providing a working environment that is free from discrimination and where everyone feels valued and respected.
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