Director* Global Development Quality Assurance

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 Development Quality Assurance 

Your main responsibilities are:

• Drives risk-based approach using modern and novel approaches and thinking to solving complex business problems
• Provide expert input to functional teams in at least of the following areas: Biostats, Data management, Clinical Trial Supply and Logistics, IRT, Pre-clinical , CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs, Companion Diagnostics, etc.
• Provide Leadership to a team of experts
• 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
• Lead and support the development of management reporting on quality key performance indicators to improve decision making
• 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
• Work with management team(s) to set quality targets and report against those targets
• Successfully collaborate with teams to identify areas for improvement and implement quality assurance measures
• Ensure that a proactive risk-based strategy is established and implemented as part of inspection readiness for key BioNTech assets
• Collaborate with key internal and external stakeholders and service providers (e.g. CROs) to develop effective business partner relationships
• Provide guidance on at least one region of health authority regulations expertise, such as FDA, EMA, MHRA
• Provide strategic leadership to the team for development of programs and strategies

• Engage with the business to identify improvement opportunities
• Encourage the business to identify and propose solutions to make meaningful changes
• Liaise with other managers and staff and provide training, tools and techniques to enable others to achieve quality standard
• Lead best practice with respect to improvement within the business
• Be a role model for stakeholder advocacy, representing their quality requirements and interests
• Ensure an effective throughput of transactional requests through the department

What you have to offer:

• Significant relevant experience in GxP operational and quality roles, typically gained over a minimum of 15 years in the industry
• Significant relevant experience in a Quality Assurance (QA) position related to clinical development and business partner relations, typically gained over 10 (ten) years of experience partnering with and providing service to business functions
• Relevant operational experience in at least one of the following areas of expertise: Biostats, Data management, Clinical Trial
• Supply and Logistics, IRT, Pre-clinical , CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs, Companion Diagnostics, etc.
• Strong and proven team leadership experience, typically gained through at least 5 years of experience
• Deep knowledge and experience in drug development, development of medical devices is a plus
• Deep knowledge of Clinical Development and Research operations and regulatory landscape
• Deep knowledge of GCP, GLP, GPVP, GCP for Labs, general understanding of GMP
• Process development expertise, industry standard problem-solving approaches, in alignment with Lean and Lean Six Sigma principles
• Knowledge in worldwide regulations and guidelines (including ICH, FDA, EMA, MHRA, ISO) related to clinical development
• Knowledge in Inspection Readiness, Inspection Preparation and Inspection Management
• Experience of driving Continuous Improvement and Quality Management Systems in a high complexity environment
• Excellent written and oral communication skills
• Ability to work in a matrix management structure, embedded in a dynamic R&D environment
• Ability to work within a team, providing support to team members and encouraging development
• Relevant IT skills
• Fluent in English, other languages a plus

Benefits for you:

• Flexible Working Time
• Mobile Office
• Work from EU Countries (up to 20 days per year)
• Company Pension Scheme
• Childcare
• Jobticket
• Company Bike
• Leave Account
• Fitness Courses
   

... and much more.
 

Have we kindled your pioneering spirit? 

Then apply now for our location Mainz Goldgrube 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 6807 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

www.biontech.com