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
• Relevant experience in building and maintaining business partner relations that include partnering with and providing service to business functions, typically gained through a minimum of 10 years
• Robust experience in interpreting GCP guidelines for the pharmaceutical industry
• Strong and proven team leadership experience, gained through at least 8 years of experience
• Relevant operational experience in at least one of the following areas of expertise: Biostats, Data Management, Clinical Trial management, IRT, Pre-clinical, CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs, Companion Diagnostics, etc.
• Deep knowledge and experience in drug development, development of medical devices, clinical development, research operations, GCP, GLP, GPVP, GCP for Labs, general understanding of GMP
• Deep knowledge of process development expertise, industry standard problem-solving approaches, in alignment with Lean and Lean Six Sigma principles
• Strong knowledge and experience in Inspection Readiness, Inspection Preparation, and Inspection Management
• Experience in collaborating with key internal stakeholders and service providers (e.g. CROs) to ensure implementation of a process where 1) clinical trial risks are detected and remediated and 2) deviations/quality issues identified are adequately investigated, including identification of root causes and implementation of robust Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (ECs)
• Experience in development and maintaining interactions with external partners, including CROs, to ensure adequate quality oversight of clinical activities
• Robust experience in worldwide regulations and guidelines (including ICH, FDA, EMA) related to clinical trial development and post-approval medicinal products, typically gained through a minimum of 15 years
• Proven leadership with teams, mentoring, and guiding team members development
• Strong experience in developing and maintaining a proactive, risk-based Clinical Quality Strategy
• Developed and managed a strategic and proactive risk-based quality oversight of the clinical trial process to ensure continuous inspection
• Experience in collaborating with key internal stakeholders and service providers (e.g. CROs) to ensure implementation of a process where 1) clinical trial risks are detected and remediated and 2) deviations/quality issues identified are adequately investigated, including identification of root causes and implementation of robust Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (ECs)
• Experience in development and maintaining interactions with external partners, including CROs, to ensure adequate quality oversight of clinical activities
• Robust experience in worldwide regulations and guidelines (including ICH, FDA, EMA) related to clinical trial development and post-approval medicinal products, typically gained through a minimum of 15 years
• Proven leadership with teams, mentoring, and guiding team members development
• Strong experience in developing and maintaining a proactive, risk-based Clinical Quality Strategy
• Developed and managed a strategic and proactive risk-based quality oversight of the clinical trial process to ensure continuous inspection readiness and compliance with Regulatory Authorities requirements, GCPs, internal standards and adherence to patients’ safety, rights and wellbeing
• Computer literacy, including MS Office suite (Excel, PowerPoint, Office, etc.)
• Experience in a quality management system
• Fluent in English and Mandarin, both written and oral

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.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company’s internal policies and applicable law.

Have we kindled your pioneering spirit?

This vacancy is to be hired at one of the following locations – Mainz Goldgrube, Cambridge Erie Street, London . Apply now for your preferred job and location through our careers site .

• 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!