Director, Clinical Quality Assurance

BioNTech SE

Director, Clinical Quality Assurance leading quality assurance activities across clinical trials. Focused on developing risk-based strategies and ensuring GCP compliance at BioNTech.

Posted 7/29/2026full-timeLondon • 🇬🇧 United KingdomLead💰 $168,100 - $268,700 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in GCP compliance and quality assurance within clinical development, with a strong focus on strategic risk management and team leadership. Proficient in developing quality strategies and ensuring inspection readiness across global clinical trials.

Highest-signal resume keywords

GCP ComplianceQuality ManagementClinical OperationsRegulatory Authority InspectionsTeam Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Quality Strategy DevelopmentRisk-Based Quality ManagementCAPA ManagementQuality Agreement ManagementInspection Readiness

Soft Skills

Proactive CommunicationTeam DevelopmentCollaboration

Tools & Technologies

MS OfficeElectronic Quality Management Systems

Industry Keywords

GCPICHFDAEMAMHRA

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead quality assurance activities across clinical development programs in global teams
Develop and implement a proactive, risk-based Clinical Quality Strategy for assigned high-priority trials or programs, ensuring inspection readiness and GCP compliance
Collaborate with internal teams, collaboration partners as well as external vendors (e.g. CROs) to identify, investigate, and remediate clinical trial risks and quality issues, including CAPAs and effectiveness checks
Actively contribute to Clinical Trial teams by providing quality guidance and reviewing key study documentation
Enable continuous inspection readiness and compliance with GCP, regulatory requirements, and internal standards
Lead or support inspection preparation, facilitation, and follow-up activities
Review and manage Quality Agreements with CROs and other vendors, ensuring compliance with agreed standards
Lead and develop a team, fostering transparency and proactive communication
Drive a culture of quality and continuous improvement across the Global Development Organization, including authoring and reviewing clinical quality procedures.

Requirements

What you’ll need

University degree in life sciences; advanced degree preferred
Profound professional experience (beyond 10 years) in a GCP-regulated environment
Strong GCP expertise gained in a senior Quality Management and / or Clinical Operations role
Strategic and Risk-based mindset with experience developing quality strategies at program level
Solid understanding of global clinical regulations and guidelines (ICH, FDA, EMA, MHRA)
Experience in team leadership and development (in the GCP environment preferred)
Experience in managing, hosting or supporting regulatory authority inspections (EMA/FDA/MHRA)
Proficiency in MS Office and electronic quality management systems

Benefits

Comp & perks

annual bonus
equity