Cambridge, MA Job Details Full-time $168,100 - $268,700 a year 17 hours ago Qualifications Quality control corrective actions Performance improvement leadership Strategic management Clinical compliance checks Clinical trial risk management Team leadership Preventive action implementation Corrective and preventive actions (CAPA) Microsoft Office Team development ICH guidelines Vendor compliance management Healthcare quality assurance policy development Leading team collaboration initiatives Regulatory readiness in healthcare Vendor quality assurance Clinical research inspection readiness Senior level Clinical program risk management Leadership FDA regulations Senior leadership Team building 10 years Full Job Description London, United Kingdom; Cambridge, US; Gaithersburg, US; New Jersey, US | full time |
Job ID:
11619 About the role: 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.
Your contribution:
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.
A good match:
Education University degree in life sciences; advanced degree preferred Experience Profound professional experience (beyond 10 years) in a GCP-regulated environment Strong GCP expertise gained in a senior Quality Management and / or Clinical Operations role. Strategic and Risk-based mindset with experience developing quality strategies at program level Solid understanding of global clinical regulations and guidelines (ICH, FDA, EMA, MHRA) Experience in team leadership and development (in the GCP environment preferred) Experience in managing, hosting or supporting regulatory authority inspections (EMA/FDA/MHRA) Proficiency in MS Office and electronic quality management systems Your benefits and remuneration: If the position is filled in the US, the Expected Pay Range is $168,100/year to $268,700/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Compensation at other locations may vary significantly. 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.
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.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. 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. We are looking forward receiving your application. Inspired? Become part of #TeamBioNTech. 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! BioNTech - As unique as you www.biontech.com
