Sabin Vaccine Institute · 17 hours ago
Senior Manager, Clinical Quality Assurance
United States
Full-time
Remote
Senior Level, Lead/Staff
$120K/yr - $165K/yr
10+ years expSabin Vaccine Institute is dedicated to making vaccines more accessible and expanding immunization globally. The Senior Manager, Clinical Quality Assurance provides technical support in risk-based quality management of clinical trials, ensuring compliance with regulatory standards and promoting a quality culture within the organization.
AssociationBiopharmaNon Profit
Responsibilities
Partner with Clinical Operations, CROs, and clinical sites to provide GXP CQA oversight, including development of risk-based clinical quality sponsor oversight initiatives in accordance with ICH E6 (R3)
Participate in product development subteams and working groups
Plan and conduct audits of CROs, clinical sites, and documentation (e.g., TMF and ISF), ensuring compliance with Sabin policies and applicable regulations
Author audit reports and oversee findings until resolution, including implementation of any CAPAs through effectiveness checks to support developmental and regulatory activities
Participate in internal and external audits/ inspections including other quality assurance assigned activities
Assist in development and implementation of sponsor oversight and quality systems to identify trends and noncompliance
Manage, create and review CQA SOP’s and documentation as required
Assist in development and implementation of quality systems to identify, initiate and monitor corrective and preventive actions to support developmental and regulatory activities
Other duties as assigned
Qualification
Required
Bachelor's degree in a scientific field; master's degree a plus
10+ years relevant experience, preferably in GxP clinical quality assurance roles
Broad knowledge of sponsor oversight, quality management, and ICH E6 R(3) compliance
Demonstrated computerized systems competence, including experience with databases, electronic quality management systems and Microsoft Office
Advanced problem-solving abilities and decision-making skills
Excellent communication skills, including strong writing abilities
Strong interpersonal skills; excellent at building productive working relationships with R&D team members and external collaborators
Demonstrated ability to work in a collaborative team environment across multiple technical functions and geographical regions
Experience in project execution using virtual platforms (e.g., Zoom/MS Teams)
Strong attention to detail, ability to manage complex tasks; highly organized, flexible, dependable and able to prioritize competing demands in order to meet deadlines
Thrive in entrepreneurial, team-oriented work environments; experience working with cross-functional teams
Ability to travel domestically and internationally to attend required staff meetings and perform clinical trial site visits and audits
Ability to work independently with minimal direct oversight
Benefits
Medical
Dental
Vision
Flexible Spending Accounts
Employer paid, Life and Disability insurance
11 paid holidays with a winter break between Christmas and New Years
Employer match on 401(k)
Company
Sabin Vaccine Institute
A non-profit organization that promotes advances in vaccine development, delivery and distribution focusing on polio, rubella, rotavirus.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$63.1MKey Investors
Biomedical Advanced Research and Development Authority (BARDA)Coalition for Epidemic Preparedness Innovations
2023-01-12Grant· $35M
2022-09-13Grant· $21.8M
2022-05-17Grant· $6.3M
Leadership Team
Amy Finan
Chief Executive Officer
Rebecca Martin
President for Global Immunization
Recent News
Sabin Vaccine Institute
2025-12-04
Global Virus Network
2025-11-27
Sabin Vaccine Institute
2025-07-22
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