Director* Operational Quality Assurance - Development & Strategy

  • Mainz
  • Senior, very experienced
  • Quality Management, Quality Assurance
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 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* Operational Quality Assurance - Development & Strategy

As Director Quality Assurance (QA) Development and Strategy, you will be making a meaningful contribution to the ongoing development of our RNA production processes. In this role, you will support us on our mission as the professional lead of the Operational Quality Assurance (OQA) development and strategy team, ensuring Good Manufacturing Practice (GMP)-conformity in the manufacturing network with the joint ventures, product development and clinical.

Your main responsibilities will be:
  • Leading the OQA development and strategy team to ensure GMP-compliance manufacturing of commercialized medicinal products at the Contract Manufacturing Organizations (CMOs)
  • Supporting new product development to fulfill the GMP compliance during pre- and post-approval
  • Functioning as the interface for clinical studies located at the CMOs
  • Executing and assuring seamless communication to BioNTech business partners, CMOs, and internal departments
  • Ensuring compliant and timely compilation of documentation or data through internal departments to support the partners (e.g. for the step from clinical to commercial)
  • Supporting preparation of inspections and audits at BioNTech sites, business partners and CMOs as needed

What you have to offer.

We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:
  • Multiple years of experience in quality assurance, quality oversight or relevant experience
  • Proven managerial leadership of technical professionals and/or in leading cross-functional teams, and respective leadership skills
  • Effective collaboration, coordination and stakeholder management skills, both in cross-functional internal and external matrix team environment
  • Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment
  • Strong project management and organizational skills, creativity and the ability to develop a flexible approach to changing conditions
  • Ability to make flexible, but thorough decisions in a highly dynamic environment utilizing risk management
  • Profound knowledge of relevant US and EU, EMA, FDA regulatory standards as well as Good Manufacturing Practices, plus deep knowledge of QA systems and GMP compliance requirements incl. regulations and standards affecting device, biologics, and pharmaceutical products
  • Refined colloquial and correspondence skills in both German and English; presentation skills adaptable to all levels of internal and external stakeholders

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

If you have any further questions, Johanna Diehl will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

https://biontech.de