Director, Global Product Quality - Quality Risk Management

Open for hire at one of the following locations –  Cambridge Erie Street, Mainz K1. - Job ID: 5758 - Hiring Manager: Catherine Watkins  

 

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.

 

Director, Global Product Quality - Quality Risk Management 

 

This position can be hired in the US or EU.

 

The Director of Global Product Quality – Risk Managment is responsible for setting up critical systems and standards related to Quality Risk Management (QRM) across the global BioNTech network.  These systems include various risk communication and risk governance strategies between BioNTech global entities and manufacturing sites as well as Quality Risk strategies to support various drug development topics in alignment with regulatory and industry expectations.  Specifically, the candidate will be working cross-functionally to define the global risk management strategy and standards for the broader BioNTech organization by developing risk-based approaches to drug development activities and Quality by Design (QbD) risk management framework.  The candidate will provide coaching, guidance, and general training on risk management and documentation, helping to create global templates and consultation on existing, ongoing, and future risk assessments.  

 

The candidate will understand worldwide quality regulations, especially related to Quality Risk Management.  The ideal candidate must be able to influence, communicate, and partner effectively with global and site development functions (R&D, process development, analytical development, Manufacturing Science and Technology, Product Supply, Regulatory, Site Quality and QC) to enable and implement a robust QRM approach.

 

Responsibilities

The areas of responsibilities will include:

• Creating structured approaches to risk communication and risk governance to support the quality network
• Leading and influencing cross-functional teams to define and effectively implement QRM processes and standards
• Setting and maintaining QRM strategy across BioNTech portfolios to support commercialization efforts.
• Set up structure to embed risk management into complex changes (e.g. global changes, multi-product or multi-site) and for proactively identifying quality risks and improvement opportunities across network.
• Provide a network for quality risk escalation and communication
• Develop, with the help of cross-functional teams, a QRM strategy to be maintained for consistency and standardization (as practical)

 

Requirements

• Minimum Bachelor’s degree (or University equivalent), Life Sciences or similar technical/scientific degree.
• Minimum of fifteen (15) years industry experience and 12 years’ experience with advanced degree.
• Previous experience in an FDA (and/or other Health Authority) regulated environment and familiar with Health Authority regulations and guidance
• Excellent communication skills and ability to influence and work cross functionally
• Demonstrates proficiency of QRM requirements and principles, and an understanding of current global and regional trends in QRM
• Experience in pragmatic implementation of cGMP and regulatory guidelines
• Knowledge of compliance requirements for manufacturing and testing Cell or Gene Therapy preferred
• Quality Engineering certification or similar preferred
• Travel may be required up to 20%

 

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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.

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