Senior Director* Clinical Quality Assurance Compliance

Open for hire at one of the following locations –  Mainz Goldgrube, Cambridge Erie Street, London. - Job ID: 7548 

 

Join our team of pioneers!

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.

 

Senior Director* Clinical Quality Assurance Compliance 

 

As Senior Director* Clinical Quality Assurance Compliance you will support key BNT regional and global business stakeholders needs. You will support and lead the team in regulatory guidance, compliance, and quality oversight, as well as establish and maintain collaborative internal & external partnerships.

 

Your main responsibilities are

 

• Ensure compliance with global health authority regulations and BNT processes
• Align with BNT QMS and other Global Development Quality Assurance (GDQA) functions
• Establish QA to QA relationships with local service providers (CROs, Labs) and BNT Collaboration Partners
• Provide Inspection support (training, preparation, and management)
• Provide global GCP compliance, guidance, and advice
• Provide Clinical QA Compliance, audit, and inspection support to the region, leveraging other global GDQA systems (e.g., QMS) and tools (Inspection Readiness Toolkit), and processes
• Seek input from global GDQA team for cross-partner collaborations and align expectations for a regional, as well as global enabling model
• Lead and/or support the Global development Operational functions as well as other QA groups, as necessary, for GCP Health Authorities inspection preparation/facilitation/follow-up activities, including CAPAs
• Support organizing both internal and external quality audits, as relevant, and ensures adequacy of the CAPAs
• Provide appropriate and relevant quality metrics to applicable stakeholders and perform trending of observations and the creation of key performance indicators across auditing activities 
• Drive risk-based approach using modern and novel approaches and thinking to solving complex business problems
• Drive change initiatives in area of expertise in partnership with functional groups, setting direction and embedding quality in the design of processes and operating models with a cross-functional approach
• Contribute to organizational quality and compliance reporting requirements
• Prepare and deliver clear, informative and timely reports for service management
• Establish and maintain regular structured interactions with key stakeholders to ensure quality management and governance frameworks are created, implemented and anchored
• Lead and collaborate with management and operational teams to adjust processes, practices as needed to meet business needs
• Successfully collaborate with teams to identify areas for improvement and implement quality assurance measures
• Provide strategic leadership to the team for development of programs and strategies
• Be a role model for stakeholder advocacy, representing their quality requirements and interests

 

What you have to offer

 

• Advanced degree academic degree in Life Sciences
• Significant experience in Good Clinical Practice (GCP) related environment, typically gained through a minimum of 15 years
• Minimally 10 years of inspection management experience