Regional Quality
4 weken geleden
**WHO ARE WE?**:
ROPU MIDI is a Regional Operating Unit consisting of 8 mid-sized European countries: Belgium, Denmark, Finland, Greece, Norway, Portugal, Sweden, and The Netherlands. MIDI is a multicultural and diverse work environment. More than 1.800 employees are striving to work together to improve lives for patients and animals in our region.
**THE OPPORTUNITY**:
As the **Medicine Quality and Compliance Lead MIDI **, you will lead the organization to identify and mitigate risks throughout the drug/device lifecycle to ensure patient safety and data integrity.
In addition, you will initiate and manage any quality and compliance topics to continuously improve our Quality Management System & act as a consultant to enable fast and efficient research and development, market authorizations and maintain licenses for our portfolio of products within the MIDI region.
This is a fantastic opportunity for an experienced professional who wants to be part of a truly innovative and revolutionary team Join us if you want to make the difference.
Work location**:Amsterdam EDGE Building.
**YOUR KEY RESPONSIBILITIES**:
- Be a quality & compliance consultant and work collaboratively as a solution oriented, pragmatic partner to Medicine functions and other applicable business partners.
- Role-model a quality culture and act as a go to person for any quality related question or concern.
- Ensure quality topics are considered in the development and implementation of (different) MIDI Target Operating Models, including Change Management, related Business processes & platforms, roadmaps & KPIs and Learning & Training needs.
- Contribute regional and local insights into the Global Quality Medicine Strategy and execute the strategy at regional and local level, reporting about risks and achievements in the Quality Management Review report.
- Continuously review and evaluate standards and processes to identify potential quality improvements and solve/mitigate compliance gaps / risks in accordance with regulatory and legal requirements, e.g., as part of Non-Compliance/CAPA Management or Functional Quality Assessments.
- Quality management and oversight of (R)OPU suppliers, liaising with Global Vendor Compliance Manager and other stakeholders (e.g. in Medicine, Sourcing, Legal and Commercial Quality) from site qualification to Non Compliances/ (CAPA)
- Management to process end.
- Contribute to audits from inputting into the annual audit planning to ensuring audit findings are appropriately investigated and actions are effectively implemented.
- Lead regulatory inspections end-to-end, representing the BI compliance position to regulatory authorities ensuring inspection findings are addressed and responses provided.
**WHAT YOU SHOULD BRING TO THE TEAM**:
- Master's degree preferred or Bachelors in a life science or other scientific discipline, or relevant work experience.
- **Around 5 years of experience in a Quality and Compliance related job.**:
- **Several years of experience in and/or in-depth knowledge of the regulations and company processes of at least one of the Medicine functions: Clinical Trial Management, Pharmacovigilance, Regulatory Affairs and/or Medical Affairs (including Medicine Operations and Epidemiology).**:
- **Excellent command of the English language **, knowledge of another language spoken in the MIDI region is a plus.
- Leadership skills with a proven track record of influencing in a matrix environment.
- Ability to influence & communicate effectively, clearly and concisely with all individuals across Boehringer Ingelheim regardless of their position or relationship.
- Strong data analytics & risk-management skills with a strong focus on sustainable solutions.
- Outstanding presentation, project management & critical thinking skills.
- Ability to lead Quality and Compliance topics and teams (including matrix or project teams) effectively to deliver the responsibilities successfully.
***WHAT WILL YOU GET IN RETURN?**:
Next to working in a **Global Top Employer **certified company that offers you the opportunity to develop and challenge yourself while learning from a fast-paced environment of our European MIDI region:
- Be part of a wellbeing-oriented organization (Premium access to **Headspace **, **OpenUP **and ongoing support and initiatives related to ways of working to help our employees to stay healthy and constantly improve the physical, emotional, mental, and spiritual well-being)
- Customized Development plan based on your role and aspirations, with several learning platforms such as LinkedIn Learning Premium, and access to international development opportunities and language classes + training programs
- A competitive salary range based on seniority and skills (plus annual bonus, 8% holiday pay and a company pension scheme)
- Green mobility package where you get compensated even for cycling to the office - which is an inspiring, sustainable (platinum-certified) building
- Hybrid workplace mod
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