Associate Director PV Compliance (m/w/d)

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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.

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

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 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 life phases: Employer-funded pension | Childcare

Apply now – We look forward to your application!

Apply to our Mainz, Germany; London, United Kingdom; Munich, Germanylocation 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.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encouragecreativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

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