Associate Director* Global Quality Assurance Operations Laboratories
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* Global Quality Assurance Operations Laboratories
The Associate Director* Global Development QA Operations Laboratories supports in the implementation of a proactive, risk-based Laboratory Quality System for the individualized mRNA cancer vaccines laboratories functions in alignment with company policies and procedures and applicable international regulations and guidelines.
Your main responsibilities are:
- Implement the risk-based laboratory operations approach for individualized mRNA cancer vaccines laboratories in alignment with bioanalytical laboratories
- Provide expert input in at least one of the following areas: Good Clinical Laboratory Practice, GLP, ISO 15189, CAP/CLIA
- Adjust processes, practices as needed to meet business needs · Engage with the business to identify improvement opportunities
- Encourage the business to identify and propose solutions to make meaningful changes
- Liaise with other managers and staff and provide training, tools and techniques to enable others to achieve quality standard
- Provide guidance to stakeholders on day-to-day questions and on the processing of deviations, CAPA measures and changes relating to laboratories
- Support Subject Matter Experts in GCP for labs, CLIA and ISO related questions
- Build and maintain strong relationships with key stakeholders to execute the company & department strategy
What you have to offer:
- Degree in life sciences, pharmacy or equivalent (university degree or medical profession)
- Completed relevant university education & broad and/or deep, specialized, task-specific expertise and skills
- Significant relevant experience in at least one of the following areas: Good Clinical Laboratory Practice, GLP, ISO 15189, CAP/CLIA, typically gained over a minimum of 7 years in the industry
- Robust understanding of Quality, GCLP/GLP/ISO 15189 principles and their impact on company’s development and business
- Significant relevant experience in a Quality Assurance position related to clinical laboratories
- Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
- Good knowledge in German and English (written and spoken)
- Computer literacy, knowledge in the use of electronic quality management systems and laboratory management systems
- Basic bioinformatic knowledge
- Highly flexible, pragmatic and supportive way of working
- Ability to work within a team and in interdisciplinary teams
Benefits for you:
- Flexible Working Time
- Mobile Office
- Work from EU Countries (up to 20 days per year)
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz Goldgrube and simply send us your application documents using our online form.
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 6629 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. 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!
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