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(Senior) Manager, Global Development Quality Assurance

Shanghai, China   |   full time   |   Job ID: 8879 

 

 

Your main responsibilities are:

  • 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 Inspection support (training, preparation, and management)
  • 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 tools (Inspection Readiness Toolkit), 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 
  • Reviews and/or implements Quality Agreements with CROs and clinical vendors and that the Quality Agreements are compiled to support GCP activities  
  • 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, GCLP and Pharmacovigilance) 
  • 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 

 

What you have to offer: 

  • Advanced degree academic degree in Life Sciences  
  • Significant experience in Good Clinical Practice (GCP) related environment, typically gained through a minimum of 5 years 
  • Minimally 3 years of inspection management and audit experience 
  • 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 3 years 
  • Robust experience in interpreting GCP guidelines for the pharmaceutical industry  
  • Relevant operational experience in at least one of the following areas of expertise: Biostats, Data Management, Clinical Trial management, IRT, Pre-clinical, CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs, Companion Diagnostics, etc. 
  • Knowledge and experience in drug development, clinical development, research operations, GCP, GLP, GVP, GCP for Labs, general understanding of GMP 
  • Knowledge of process development, industry standard problem-solving approaches
  • Strong knowledge and experience in Inspection Readiness, Inspection Preparation, and Inspection Management
     

 

 

Your Benefits:

 

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.

 

How to apply:

 

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

 

Please note:

Only applications sent via our online form shall be considered. 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.

 

We are looking forward receiving your application.

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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. 

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