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BioNTech SE · 4 days ago

Director, Clinical Quality Assurance

Cambridge, MA

Full-time

Onsite

Director/Executive

$202K/yr - $247K/yr

10+ years exp

BioNTech SE is a leading biopharmaceutical company focused on innovative therapies. The Director, Clinical Quality Assurance Compliance will lead quality assurance activities across clinical development programs, implementing a proactive quality strategy and ensuring compliance with GCP standards.

Health Care

Responsibilities

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

Qualification

GCP expertiseQuality ManagementClinical OperationsRegulatory complianceRisk-based strategyMS Office proficiencyTeam leadershipInspection preparationFluent in EnglishMandarin (plus)