Senior Manager, Global Development Quality Assurance

BioNTech SE

Senior Manager ensuring local compliance with regulations and QA processes in Global Development at BioNTech. Supporting clinical audits and vendor assessments for effective quality assurance.

Posted 7/9/2026full-timeShanghai • 🇨🇳 ChinaSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Ensure compliance with unique local regulations and BNT processes in China
Support BNT QMS and other global GDQA functions
Ensure proper assessment of local vendors
Support QA to QA relationships with local service providers (CROs, Labs) and BNT Collaboration Partners
Provide proactive local GCP compliance, guidance, and advice
Provide local Clinical QA Compliance, audit, and inspection support to the country, leveraging other global GDQA systems (e.g., QMS) and processes
Supports the Global development Operational functions as well as other QA groups, as necessary, for GCP Health Authorities inspection preparation/facilitation/follow-up activities, including CAPAs
Provides appropriate and relevant quality metrics to applicable stakeholders and can perform trending of observations and the creation of key performance indicators across auditing activities
Supports the creation and updates of the risk-based audit strategy and the derived audit plan for the functions and activities under the oversight of the Global Development QA (including GCP and GCLP)
Coordinates and oversees the audits performed by external vendors, including acting as the interface with BioNTech internal functions involved with these audits
Performs audits and oversees the adequate follow-up of issues identified during audits
Drives risk-based approach using modern and novel approaches and critical thinking to solving complex business problems
Provide input to functional teams.

Requirements

What you’ll need

Advanced degree academic degree in Life Sciences
Robust experience in Good Clinical Practice (GCP) related environment, typically gained through a minimum of 3 years
Relevant experience in building and maintaining business partner relations that include partnering with and providing service to business functions, typically gained through a minimum of 1 year
Experience in interpreting GCP guidelines for the pharmaceutical industry
Knowledge and experience in drug development, clinical development, research operations, GCP, GCP for Labs
Knowledge of process development, industry standard problem-solving approaches
Knowledge and experience in Inspection Readiness, Inspection Preparation, and Inspection Management is preferred.

Benefits

Comp & perks

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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Hard Skills & Tools

GCP ComplianceClinical DevelopmentDrug DevelopmentQuality MetricsAudit PreparationCAPA ManagementProcess DevelopmentInspection ManagementResearch OperationsGCP Guidelines Interpretation

Soft Skills

Critical ThinkingProblem SolvingCollaborationCommunicationRelationship Building