Quality & Compliance Lead (m/f/d) - 18 months fixed term contract
Boehringer Ingelheim RCV GmbH & Co KGOur 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
With immediate effect, we are seeking an experienced Quality & Compliance Lead (QCL) to join our team. In this position, you will act as the subject matter expert for Quality and Compliance, ensuring adherence to Good Clinical Practice (GcP) and Good Pharmacovigilance Practice (GvP) standards across the entire drug and medical device lifecycle. You will proactively manage quality and compliance to safeguard patient safety and data integrity, while collaborating with multiple internal and external stakeholders.
Tasks & responsibilities
- Develop and maintain aspects of our Quality Management System (QMS) and lead quality reviews and plans.
- Serve as a consultant for quality and compliance, assessing regulatory changes and guiding business partners.
- Promote Quality by Design (QbD) principles and implement global procedures locally.
- Manage regulatory inspections and audits, including preparation, execution, and follow-up.
- Manage non-compliances, leading as a quality subject matter expert in partnership with the key stakeholders, working on investigations and CAPA processes as well as performing periodic reviews of specific supplier management topics.
Requirements
- Master’s degree preferred (or Bachelor’s) in Life Sciences or related scientific discipline.
- Preferably 8+ years in clinical trial management or pharmacovigilance and 5+ years in quality/compliance roles/activities.
- Deep knowledge of ICH GcP or GvP regulations and experience with inspections and audits.
- Strong understanding of QMS, QbD, and CAPA processes within a global matrix organization.
- Excellent communication, leadership, stakeholder management and analytical skills combined with project management expertise.
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 minimum gross annual salary for this position is € 73.800 (full-time) according to the classification in the collective bargaining agreement for the chemical industry. Depending on professional experience and qualifications, we offer an overpayment.
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 Weronika Krzeminska.
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.
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