Sabin Vaccine Institute logo
Sabin Vaccine Institute

We are a global health non-profit on a mission to make vaccines more accessible, enable innovation & expand immunization

Senior Manager, Clinical Quality Assurance

QA EngineerQA EngineerFull TimeRemoteSeniorTeam 51-200Since 1993H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

$120K - $165K / year

Seniority

Senior

Bachelor Degree9 yrs expEnglish

Job Description

• Provide comprehensive technical support and expertise in risk-based quality management of clinical trials • Oversee internal and external compliance with ICH E6 (R3), organizational procedures, and applicable regulatory standards • Support the Marburg Vaccine (cAd3-Marburg) and Sudan Virus Vaccine (cAd3-Sudan) development activities • Promote a quality culture within the organization • Partner with Clinical Operations, CROs, and clinical sites to provide GXP CQA oversight • Develop risk-based clinical quality sponsor oversight initiatives • Plan and conduct audits of CROs, clinical sites, and documentation, ensuring compliance with policies and regulations • Author audit reports and oversee findings until resolution, including implementation of any CAPAs through effectiveness checks • 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.

Job Requirements

  • 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 (R3) compliance
  • Demonstrated computerized systems competence, including experience with databases, electronic quality management systems and Microsoft Office
  • Advanced problem-solving abilities and decision-making skills
  • 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 to meet deadlines
  • 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.

Benefits

  • medical, dental, and vision coverage
  • flexible spending accounts
  • flexible vacation leave
  • sick leave
  • short-term and long-term disability options
  • 10 federal holidays
  • end of the year winter break
  • employer matching 401(k) plan

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