Director, Clinical Quality Assurance

Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID : 9897

As Director, Clinical Quality Assurance Compliance you will lead quality assurance activities across clinical development programs in global teams. This role focuses on implementing a proactive, risk-based quality strategy, ensuring GCP compliance, fostering a culture of quality within the Global Development Organization whilst supporting delivery of our clinical trial portfolio.

Responsibilities

• Develop and implement a proactive, risk-based Clinical Quality Strategy for assigned high-priority trials or programs, ensuring inspection readiness and GCP compliance
• Collaborate with internal teams, collaboration partners as well as external vendors (e.g. CROs) to identify, investigate, and remediate clinical trial risks and quality issues, including CAPAs and effectiveness checks
• Actively contribute to Clinical Trial teams by providing quality guidance and reviewing key study documentation
• Enable continuous inspection readiness and compliance with GCP, regulatory requirements, and internal standards
• Lead or support inspection preparation, facilitation, and follow-up activities
• Review and manage Quality Agreements with CROs and other vendors, ensuring compliance with agreed standards
• Lead and develop a team, fostering transparency and proactive communication
• Drive a culture of quality and continuous improvement across the Global Development Organization, including authoring and reviewing clinical quality procedures.
• Acting as an ambassador for quality : ensuring that quality is an enabler of delivery.

Qualifications

Education

Experience

Expected Pay Range : $202000 / year to $247000 / year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).

Your Benefits :

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried / Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to :

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge's thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

Apply now - We look forward to your application!

Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.

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BioNTech, the story

At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

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