Senior Manager, Quality Systems

Job Category : Product Development Center, General Requisition Number : MANAG001371 Posted: November 26, 2024 Employment Type: Full-Time

Locations

Showing 1 location:

• NY Office IAVI 125 Broad St 9th Floor New York, NY 10004, USA
• Remote - United States
• South Africa IAVI Ground Floor, Collingwood Building Black River Park Cape Town, SA 7925, ZAF

Job Title:

Senior Manager, Quality Systems Location: New York, NY, US-Remote, Nairobi, Kenya, Cape Town, South Africa, Remote-South Africa, Amsterdam, Netherlands, Remote-United Kingdom Reporting to: Director, Quality Assurance

Position Summary:

Are you an experienced drug development Quality Systems leader who’s looking for an opportunity to make an impact on global public health? IAVI is seeking a Sr. Manager, Quality Systems who is critical in the development, maintenance, and continuous improvement of IAVI’s Quality Management Systems (QMS). In this key position, the Senior Manager ensures the strategic design, development, implementation, maintenance, and enhancement of a robust QMS to support GxP compliance. Join IAVI and apply your QA Systems expertise to a critical mission in public health!

Key Responsibilities:

• Collaborates with the Director, Quality Systems to develop, implement, and monitor the effectiveness of all core Quality Systems in compliance with applicable regulations and industry standards (e.g. Deviation Management, CAPA, Change Control, Documentation, Training).
• Provides direction and support to the organization on quality system related matters.
• Manages the resolution of complex compliance and/or quality systems issues as they arise.
• Leads the strategic approach to advance the GxP training program, including leading the development and delivery of training initiatives.
• Serves as a Subject Matter Expert (SME) to provide user training and administrative support for IAVI’s electronic document, quality, and learning management systems.
• Manages the use and continuous improvement of the electronic Quality Management System, eQMS, working with the Document Manager to oversee document lifecycle management.
• Drives a culture of quality throughout IAVI and promotes a growth mindset among team members.
• Support the development of the Quality Department budget in alignment with routine planning cycles.
• Performs other duties as assigned by the Director.

Education and Work Experience:

• Bachelor’s Degree in the life sciences or technical field is required.
• Minimum of 6 years of experience in QMS roles within GxP environment is required.
• Minimum of 2 years management experience with direct reports required.

Qualifications and Skills:

• Previous experience in quality management system gap assessment, design, build, and deployment as the primary QA owner.
• Previous QA experience within GxP late-stage development environments.
• Strong knowledge of GxP regulations, Good Documentation Practices, ALCOA+, and data integrity principles.
• Experience with electronic document management systems.
• Experience leading and managing quality projects.
• Working knowledge of Microsoft Word, Excel, PowerPoint.
• Experience designing and implementing phase appropriate, right-sized QMS.
• Experience in the creation of training materials, process flow diagrams (e.g. Lucidchart) and presentations.
• Experience with late stage (Phases 2b-3) clinical development preferred.
• Experience with Veeva QualityDocs and UL ComplianceWire preferred.
• Strong analytical and problem-solving skills.
• Ability to manage multiple priorities with minimal supervision.

Organizational Overview:

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions.

Compensation and Benefits Information for US-Based Candidates:

Annual base salary for this position is: $120,000.00 - 135,000.00. This position offers competitive benefits such as annual bonus, generous retirement savings plan, and competitive health insurance benefits. IAVI CORE VALUES:

• Dedication to the Mission
• Innovative Evolution
• Integrity
• Collaboration

IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. #J-18808-Ljbffr