Manager* CTSM Excellence Audits & Inspections

Open for hire at one of the following locations –  Mainz Goldgrube. - Job ID: 5956 

 

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.


 

Manager* CTSM Excellence Audits & Inspections 

 

Your Responsibilities: 

  • You define and manage initiatives of all Clinical Trial Supply Management Audits & Inspections activities in global Phase I-III clinical trials (R&D Programs) 
  • You provide insights and support inspection readiness to other functions 
  • You lead preparation of internal and external audit activities (incl. self-inspections, audits at vendors, etc.) and guide the team through the audit or inspection process 
  • You coordinate follow-ups from inspections & audits and timely closure of activities 
  • You participate in bi-weekly Risk Management sessions 
  • You manage process improvement initiatives related to audit & inspection findings 

 

 

What you have to offer: 

  • Relevant professional experiences (usually +3 years) in Pharmaceutical or Biotech or any other equivalent industry setting  
  • Proven Audit and/or Inspection experience, relevant certificates or qualifications are a surplus 
  • Proven track record in preparation and participation of audits and inspections 
  • Deep Understanding of Quality Management Systems 
  • Deep knowledge of GMP and GCP principles (e.g., SOPs, Process Controls, etc.)
  • Experience in dealing with agencies/authorities e.g., FDA, EMA, BSI, etc. 
  • Experience in compilation of regulatory documents preferred 
  • Standard office software proficiency (e.g., MS Office) 
  • Business-professional English language skills 

 

  

Preferred Requirements 

  • Ability to solve multi-layered and dynamic activities  
  • Self-motivated with strong problem-solving and learning skills 
  • Able to accurately work under pressure in a versatile environment  
  • Willing and able to take over responsibility and ownership 
  • Ability to create independent analyses and develop new solutions  
  • Excellent organizational and communicative skills 
  • Openness to explore on new topics for setting up the trend 


 

Benefits for you

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.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.
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.

 

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Mainz GoldgrubeApply now for your preferred job and location through our careers site.


*BioNTech does not differentiate on the basis of race, colour, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, veteran status, genetic information, or any other characteristic protected by applicable law. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!