PV Regulatory Intelligence Manager for Global Operations
5 days ago
About the Job
We are seeking an experienced PV Regulatory Intelligence Manager for Global Operations to join our QPPV Office team.
Your primary responsibility will be managing and overseeing our global PV regulatory intelligence function.
This entails assessing and interpreting new legislation and guidelines, ensuring their effective implementation to enhance value for our patients and for ALK.
Key Responsibilities
- Global PV Regulatory Intelligence
- Assessing and interpreting new legislation and guidelines.
- Ensuring effective implementation to enhance value for our patients and for ALK.
- PV Deviation Management
- Conducting root cause analyses, criticality assessments, and developing CAPAs.
- PV Supplier Management
- Serving as the primary contact for our preferred PV suppliers.
- Ensuring up-to-date PV Agreements and monitoring performance according to defined metrics.
- PV System Implementation and Maintenance
- Assisting affiliates and commercial partners with implementing and maintaining local PV system master files.
- Ensuring local QPPVs have access to relevant global data necessary to fulfill their responsibilities.
- Audit and Inspection Coordination
- Coordinating and managing audits and inspections to ensure compliance with established standards.
About You
We imagine that you bring:
- A master's or bachelor's degree in a related life science field.
- A robust theoretical foundation coupled with practical experience in PV and a strong focus on quality aspects.
- Comprehensive knowledge of international PV regulations and guidelines.
- A strong analytical mindset and a structured approach to problem-solving.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office applications, particularly MS Word and MS Excel.
- Fluency in both spoken and written English.
What We Offer
Become part of ALK, a global pharmaceutical company specializing in allergy immunotherapy.
We provide an attractive working environment for individuals seeking personal and professional growth.
You will be part of an engaged and informal team that values skill and knowledge creation.
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