Senior Manager, Clinical Quality Assurance (CQA)

 Reports to: Senior Director, Quality

Location: Remote Work

Why Sabin:

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary: 

The Senior Manager, Clinical Quality Assurance (CQA) provides comprehensive technical support and expertise in risk-based quality management of clinical trials. The role involves overseeing internal and external compliance with ICH E6 R(3), Sabin organizational procedures, and applicable regulatory standards. Additionally, responsibilities include supporting the Marburg Vaccine (cAd3-Marburg) and Sudan Virus Vaccine (cAd3-Sudan) development activities, outbreak response, ongoing internal quality system build out and promoting a quality culture within the organization.

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)
• 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 

• Bachelor’s degree in a scientific field; master’s degree preferred
• 9+ 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
• 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 as demonstrated ability to work in a collaborative team environment across multiple technical functions and geographical regions
• Ability to work independently with minimal direct oversight

Other:

• Must demonstrate interest in furthering Sabin’s mission
• Subject to a criminal background investigation 
• Request for three professional references
• Verification of education/degrees

Sabin’s philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the starting annual salary for this position ranges from $120,000 - $165,000. The exact compensation may vary based on skills, experience, training, certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.

Sabin offers a competitive benefits package that includes Medical, Dental, Vision and Flexible Spending Accounts. Employer paid, Life and Disability insurance along with 11 paid holidays with a winter break between Christmas and New Years. Employer match on 401(k).

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.