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.
Your main responsibilities are:
* 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.
What you have to offer.
* 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
Your Benefits:
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
Apply now - We look forward to your application!
Apply to our Mainz, Germany; London, United Kingdom; Munich, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 9214 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.