Associate Director* Clinical Quality Assurance Compliance
Open for hire at one of the following locations – Mainz Goldgrube. - Job ID: 6853
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.
Associate Director* Clinical Quality Assurance Compliance
The Associate Director* Clinical QA Compliance supports and oversees the proactive and risk-based Quality Strategy implementation in the clinical development activities within a portfolio.
Your main responsibilites are:
- Support and collaborate with key stakeholders in portfolio and study teams to ensure that risks are detected and remediated
- Provide guidance to day-to-day questions arising from Clinical trials deliverables
- Interact with CROs to ensure adequate quality oversight on clinical activities
- Collaborate with Clinical Development Operations to drive initiatives relevant to outsourced activities
- Support inspections preparation and facilitation in collaboration with other QA groups
- Support audits and inspections as well as follow-up activities including CAPA preparation
What you have to offer:
- At least 5-8 years of experience in Good Clinical Practice (GCP) and Quality Assurance Environment in Pharmaceutical Clinical Development or Clinical Research Organization
- In depth expertise in worldwide regulations (including FDA, EMA) related to clinical development and post approval
- An academic degree in Life Science (advanced degree preferred)
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. 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!