Biologist (m/w/d)

BioNTech SE

55131 Mainz am Rhein - Deutschland

Biologe/Biologin Arbeit Vollzeit ab 30.09.2025

Beschreibung

Director Clinical Quality Assurance Compliance
London, United Kingdom; Mainz, Germany | full time | Job ID:9664

As Director Clinical Quality Assurance Compliance you will lead quality assurance activities across clinical development programs in global teams. This role focuses on implementing a proactive, risk-based quality strategy, ensuring GCP compliance, fostering a culture of quality within the Global Development Organization whilst supporting delivery of our clinical trial portfolio.
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
Acting as an ambassador for quality: ensuring that quality is an enabler of delivery

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
Fluent in English (German is a plus)
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

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