(Senior) Manager* Quality Assurance Vendor Compliance Management

Become a member of the BioNTech Family!

As a part of our team of more than 4.000 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.

 

As (Senior) Manager* Vendor Compliance Management you are part of the Global Development Quality Assurance team. The Vendor Compliance Management group supports and coordinates qualification and oversight of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP) vendors.

Your main responsibilities are

 

• Qualify vendors as per the SOPs and ensure ongoing qualified status
• Establish strong working relationship with internal stakeholders within GDQA and GDO to support vendor compliance related activities
• Ensure vendor’s oversight via establishment of quality agreements and identification and collection of key quality metrics; perform trending of quality issues at vendors
• Ensure CAPA completion and effectiveness checks for quality issues of vendors – when applicable
• Participate in QA - QA monthly meetings with vendors – when applicable
• Maintain all required documentation as per the SOPs and regulatory requirements
• Contribute to having an updated and qualified vendor list
• Support transition and implementation of Veeva related activities for supplier quality management
• Support inspection readiness activities 
• Support Vendor Compliance Management continuous improvement efforts
• Support audit related activities when required

 

What you have to offer

 

• 3-6 years of experience in a GCP environment in the Pharmaceutical or CRO industry
• 1-3 years of experience in Quality functions such as vendor management / auditing / compliance
• Comprehensive knowledge of ICH GCP and GVP guidelines and other international GxP regulations as appropriate
• An understanding of vendor oversight and qualification strategies
• Good understanding of Clinical Development activities
• Knowledge of applicable regulations
• Excellent English skills, both written and verbal

• Computer literate and proficient in Microsoft Office suite

 

 

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, 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 1000 (please indicate for inquiries)

We look forward to your application!

*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

www.biontech.com