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

• 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
• Fluent in English (Mandarin is a plus)

 

Expected Pay Range: $202000/year to $247000/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.

 

 

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:

 

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

 

…and more! More details to be shared.
 

 

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 thrivin