Director* Clinical QA Compliance

Open for hire at one of the following locations –  London, Mainz Goldgrube. - Job ID: 7471 

 

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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* Clinical QA Compliance 

 

The Director* Clinical Quality Assurance Compliance leads the GCP Quality Strategy implementation in the clinical development activities, including, but not limited to the below.

 

Your main responsibilities are:

 

1. Within the assigned portfolio and clinical studies:

  • Ensure that a proactive, risk-based Clinical Quality Strategy is established and implemented within your respective portfolio
  • Collaborate with key internal stakeholders and service providers (e.g. CROs) to ensure implementation of a process where clinical trial risks are detected & remediated, and 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)
  • Evaluate and plan across respective portfolio for upcoming key trial milestones to ensure that functional teams are inspection ready
  • You are an active member of the Clinical Study Teams (both in the Clinical Operations and Core Teams), through participating in meetings, reviewing key clinical study relevant documentation and providing quality guidance for day-to-day issues and questions arising from clinical trial deliverables
  • As required, interact with external partners, including CROs, to ensure adequate quality oversight of clinical activities
  • Develop and manage 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
  • Lead and/or support the GDO 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
  • Review and/or implement Quality Agreements with CROs and clinical vendors
  • Ensure that the executed Quality Agreement requirements are complied with by BioNTech external partners supporting GCP activities
  • Provide appropriate and relevant Quality metrics to applicable stakeholders

2. At an organisational level:

  • Drive a culture of quality in BioNTech Global Development Organization to positively impact the business and implement the overall strategy and vision of the Global Development Quality Organization
  • Collaborate with key stakeholders to execute the company and department strategy, following proactive and risk-based quality approaches, leverages Quality by Design principles, and provides QA and GCP expertise and guidance to achieve company objectives
  • Manage and develop a Clinical QA Compliance team from different geographical locations, while continuously upholding the principles of transparency, speak up, and proactivity
  • As required, lead or support the continuous improvement initiatives (including workstreams) within BioNTech and ensure that areas identified as weaknesses are properly addressed and executed for sustainability
  • Support authoring and review of procedural documents covering clinical quality aspects
  • Deputize for the Sr. Director QA Compliance, as necessary

 

What you have to offer:

 

  • Degree in life sciences, pharmacy or equivalent (university degree or medical profession)
  • Completed relevant university education & broad and/or deep, specialized, task-specific expertise and skills
  • Minimum of 10 years of experience in a Good Clinical Practice (GCP)-regulated environment, of which minimum 6 years in a Quality Assurance (QA) position
  • Inspection management experience, with at least one submission experience with a health authority (ICH, FDA, EMA) and in-depth expertise in worldwide regulations and guidelines related to clinical trial development and post-approval of medicinal products
  • Robust understanding of Quality, GCP principles and their impact on company’s development and business
  • Multiple years of experience in Quality Assurance (QA) functions in Clinical Development such as quality systems or quality/audit/inspection/risk management
  • At least 5 years of functional/cross-functional and/or disciplinary leadership experience with convincing track record of leading teams
  • Computer literacy, including MS Office; knowledge in the use of electronic quality management systems and ability to function independently within an environment that relies heavily on technology and computerized systems
  • Fluent in English (written and spoken)


 

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 – London, Mainz GoldgrubeApply 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!