Associate Director* Operational Quality Assurance - Compliance External Manufacturing

  • Mainz
  • Work experience
  • 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.

Associate Director* Operational Quality Assurance - Compliance External Manufacturing

As Associate Director Quality Assurance (QA) and Compliance External Manufacturing, 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 Lead of the Operational Quality Assurance (OQA) compliance external manufacturing team, ensuring Good Manufacturing Practice (GMP)-conformity in the manufacturing network.

Your main responsibilities will be:
  • Guiding the Contract Manufacturing Organization (CMOs) quality assurance team to ensure GMP-compliance manufacturing of commercialized medicinal products in the CMO manufacturing network
  • Creating of guidelines, monitoring of activities (e.g. Corrective And Preventive Action (CAPAs)), reviewing and approving QA-processes and documentation management, and GMP-documents from the CMO network
  • Managing the insurance of packaging and artwork coordination
  • Discussing and leading decision-making processes for external partners in GMP questions
  • Training, managing and mentoring the team to achieve the quality goals
  • Executing and assuring smooth communication to internal and external partners to ensure compliant and timely product delivery

What you have to offer.

We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:
  • University degree in (Life) Science, Engineering or a medical field
  • Several year of work experience in a biotech or pharmaceutical company
  • Proficiency in multiple quality systems incl. exception management, change control, document control, product release, supplier quality, etc. 
  • Profound knowledge of relevant US and EU, EMA, FDA regulatory standards as well as Good Manufacturing Practices 
  • Good combination of strategic and operational skills
  • Ability to make flexible, but thorough decisions in a highly dynamic environment utilizing risk management
  • Strong leadership skills, including effective collaboration, coordination and stakeholder management skills, both in cross-functional internal and external matrix team environment
  • High carefulness and accuracy in the way of working, conscientiousness and detail-orientation
  • 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