Director* Clinical QA Compliance

Open for hire at one of the following locations –  Mainz Goldgrube, Cambridge Erie Street, Cambridge Hamilton Street, Cambridge Sidney Street, Gaithersburg, London. - Job ID: 5882 

 

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.

 

Director* Clinical QA Compliance 

 

Your main responsibilities are:

 

• Ensure that a proactive, risk-based Clinical Quality Strategy is established and implemented as part of inspection readiness for key BioNTech assets
• Oversee the preparation and management of BioNTech organization for inspection of clinical activities by main Regulatory Authorities (including but not limited to FDA, EMA, MHRA and PMDA)
• Collaborate with key internal stakeholders and service providers (e.g. CROs) to ensure implementation of the inspection readiness strategy
• Interact with external partners, including CROs, to ensure adequate quality oversight of clinical activities
• Develop and manage a strategic and proactive risk-based quality oversight of the clinical trial process to ensure continuous inspection readiness and compliance with Regulatory Authorities requirements, GCPs, internal standards and adherence to patients' safety, rights and wellbeing
• Support and coordinate GDO functions in the preparation of responses and follow up of issues identified during Regulatory Authorities inspections

 

 

What you have to offer:

 

• Minimum of 10 (ten) years of experience in a a Quality Assurance (QA) position related to clinical development
• Strong knowledge and experience in Good Clinical Practice (GCP) environment
• Expertise in worldwide regulations and guidelines (including ICH, FDA, EMA, MHRA) related to clinical development
• Expertise in Inspection readiness, Inspection Preparation and Inspection Management
• Team leadership experience preferred.
• University degree in life sciences

 

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 Goldgrube, Cambridge Erie Street, Cambridge Hamilton Street, Cambridge Sidney Street, Gaithersburg, London. Apply 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!