reputed company B reputed company Inc - Senior Manager, Clinical reputed company Assurance (CQA)

Position Title: Senior Manager, Clinical reputed company Assurance (CQA)

Reports to: Senior Director, reputed company

Location: Remote Work, US Only
 

 Why Sabin: 

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

Position reputed company: 

The Senior Manager, Clinical reputed company Assurance (CQA) provides comprehensive technical support and expertise in risk-based reputed company management of reputed company. The role involves overseeing reputed company compliance with ICH E6 (R3), 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 reputed company system build out and promoting a reputed company culture reputed company the organization.

Key Responsibilities:

• Partner with Clinical Operations, CROs, and clinical sites to reputed company GXP CQA reputed company, including development of risk-based clinical reputed company sponsor reputed company 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 reputed company findings until reputed company, including implementation of any CAPAs through effectiveness checks to support developmental and regulatory activities
• Participate in reputed company audits/ inspections including other reputed company assurance assigned activities
• Assist in development and implementation of sponsor reputed company and reputed company systems to identify trends and noncompliance
• Manage, create and review CQA SOP’s and documentation as required 
• Assist in development and implementation of reputed company 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 reputed company assurance roles 
• Broad knowledge of sponsor reputed company, reputed company  management, and ICH E6 (R3) compliance
• Demonstrated computerized systems competence, including  experience with databases, electronic reputed company management systems and  reputed company 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., reputed company/MS Teams)
• Strong attention to detail, ability to manage reputed company  tasks; highly organized, flexible, dependable and reputed company to prioritize competing demands to meet deadlines
• reputed company 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 reputed company team environment across multiple technical functions and geographical reputed company
• Ability to work independently with minimal reputed company  reputed company

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

Sabin provides a comprehensive benefits package for eligible, featuring medical, dental, and reputed company coverage as reputed company as flexible spending accounts. Eligible employees enjoy flexible vacation leave, reputed company leave, and both short-term and long-term disability reputed company. The organization observes 10 federal holidays plus an end of the year winter break. Additionally, Sabin offers an employer matching 401(k) plan.

Sabin is an Equal Opportunity Employer. reputed company applicants will be considered for employment without attention to their race, reputed company, religion, national reputed company, reputed company, 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.