02 oct
|
Allucent
|
Madrid
We have a rare opportunity for a VP, Quality Assurance to join our A-team. In this role you will be responsible for leading the strategic vision, operations, and financial health of the Quality organization. You will be responsible for planning, preparation and execution oversight of customer audits/inspections. You will lead approaches for quality KPIs/metrics and other activities in accordance with the standard operating procedures, regulatory guidelines, executed client contract and the clients’ expectations. You will take part in the Allucent Leadership team.
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
Key responsibilities:
• Lead to identify, develop and implement the business strategy for the Quality department.
• Develop and agree upon operating procedures / business processes
• Head over (executive and senior) management team meetings
• Review audit reports (e.g., process, project, vendor), as applicable
• Maintain and develop organizational culture, values and reputation
• Report to applicable internal stakeholders on business strategy, planning, results and performance for the Quality department.
• Support regulatory authority inspections as needed
• Represent Quality organization in key meetings (e.g., Monthly Business Review, Board).
• Monitor and assure client satisfaction on existing projects for the Quality department
• Identify key accounts and maintain strong long-lasting relationships to win new and repeat business
We're looking for someone with:
• Life science, healthcare and/or business degree
• Minimum 15 years of relevant work experience
• Minimum 12 years of experience in drug development and/or clinical research
• Thorough knowledge of ICH-GCP (R2), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11
📌 VP, Quality Assurance (Madrid)
🏢 Allucent
📍 Madrid