Associate Director PV Compliance (m/w/d)
Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID:9214
The Associate Director Safety Compliance performs specific duties in the Medical Safety & Pharmacovigilance (MSPv) department to ensure compliance with BioNTech’s quality standards and global regulations. The Associate Director Safety Compliance is assigned to support the set-up and maintenance of safety compliance activities to ensure audit and inspection readiness.
Oversee safety compliance tracking and reporting
Manage and update procedural documents related to safety processes, ensure all medical safety and pharmacovigilance activities are aligned with BioNTech’s quality standards, global regulations, and ethical requirements
Perform process gap assessment as required and implement risk registers
Support safety compliance and inspection readiness activities
Active involvement in the preparation, conduct and follow-up of GxP regulatory inspections and audits impacting MSPv
Conduct of MSPv focused mock inspections and lessons learned sessions as required from audit and inspection preparation perspective
Process and document of non-conformities and CAPAs for the MSPv department
Overall monitoring, tracking and analysis of deviation and CAPAs
Contact person within the MSPv department for the relevant Veeva module for issue management
Support BioNTech's Regulatory Intelligence activities and oversee PV Intelligence to develop, implement and continuously improve procedural documents and processes.
Advanced degree in life sciences / healthcare (or clinically relevant degree)
Expert knowledge of global pharmacovigilance regulations and processes, strong understanding of ICH, GVP/GCP modules as well as EU- and US- legislations
At least 5 years of experience in Pharmacovigilance and/or Quality Assurance in biotech or pharmaceutical industry
Experience with GxP audits and inspections and deviation and CAPA management
Expertise in authoring procedural documents
Proactive, solution-oriented with a collaborative mindset
Ability to work effectively in global, cross-functional teams
Good communication skills; is able to express complex matters in concise, clear language
Fluency in written and spoken English
Ability to accept shared responsibility with other team members to achieve results
It's our priority to support you:
Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare