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.
