Regional Quality & Compliance Lead
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 Regional Quality and Compliance Lead, you will lead the Human Pharma Medicine organization to identify and mitigate risks throughout the drug/device lifecycle to ensure patient safety and data integrity. You will partner with all Medicine departments with a focus on Pharmacovigilance and Regulatory Affairs, but also with Clinical Development & Operations and Medical Affairs.
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.
The work location for this role is 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 model – flexibility to work from home within the respective country and the office and 31 vacation days to re-energize
• A very diverse team (currently over 40 nationalities) that enjoys fun activities and celebrations (e.g., Team events, Christmas Party) and values a respectful working atmosphere!
What’s next?
We will have a look at your CV and cover letter. If we see a match, we will invite you for a video call interview to get to know each other. Are we still positive? We might schedule a second interview and possibly a small Business Case. We will keep you posted during the process!
If you have any questions related to the recruitment process, please do not hesitate to contact Talent Acquisition MIDI: TalentAcquisitionMIDI.EU@boehringer-ingelheim.com
DIVERSITY & INCLUSION
At Boehringer Ingelheim we share the opinion that diversity and inclusion is essential for the growth of our business and that our strengths and competitive advantage are also the result of the diversity of our company – diversity across the three dimensions of inclusion: Gender, Geography and Generation. Our people are part of a deep-rooted, family company philosophy that welcomes everyone! We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Screening:
In order to comply with applicable export control laws, Boehringer Ingelheim periodically screens business relations (including job applicants) against sanctioned party lists (“SPL”). These checks may be performed by Boehringer Ingelheim or by any of its Affiliates. You acknowledge that Boehringer Ingelheim and/or its Affiliates will screen you against SPL and that for this purpose your personal data may be processed in relevant databases, including databases of third-party vendors that perform SPL screening for or on behalf of Boehringer Ingelheim or its Affiliates which may be located or accessible outside the EU. Boehringer Ingelheim is committed to ensuring an adequate level of protection of your personal data.