Associate Director or Senior Manager, HSR Quality Systems and Compliance at IAVI

IAVI is seeking a AD/Sr. Manager, Quality Systems who is key in the development, maintenance, and continuous improvement of IAVI’s HSR Quality Management System (QMS). In this key position, the Senior Manager supports the design, development, implementation, maintenance, and enhancement of a robust QMS to support HSRQ compliance with GCP and GCLP requirements.  

Join the mission at IAVI and apply your QA Systems expertise to a critical mission in public health!

Key Responsibilities:

Quality Systems and Quality Assurance Activities:

• Collaborates with the Senior Director, HSRQ to develop, implement, and monitor the effectiveness of core HSR Quality Systems in compliance with applicable regulations and industry standards (e.g. Deviation Management, CAPA, Change Control, Documentation, Training).
• Provides guidance and support to the HSRQ organization on quality system related matters.
• Leads the HSRQ approach to advance our 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 an of the electronic Quality Management System, eQMS,
• Act as point person for HSRQ QMS system requirements and work closely with IT to ensure continuous improvement of our eQMS.
• Monitors compliance with HSR Quality System requirements according to predetermined metrics and report on those.
• Supports Document Management and oversees HSRQ document lifecycle management, including eTMF; This includes activities to mitigate risks specific to document management.
• Participates in additional quality processes including deviation, CAPA, and change management where the scope requires QMS SME input.
• Drives a culture of quality throughout IAVI and promotes a growth mindset among team members.
• Performs other duties as assigned by the Director.

Education and Work Experience:

• Bachelor’s Degree in the life sciences, technical or related field is required.
• Minimum of 6 years of experience in quality management roles within GCP/GCLP environment is required; Minimum of 8 years’ experience for Associate Director level required.
• Minimum of 3 years’ experience managing an eQMS for GCP/GCLP is highly preferred.

Qualifications and Skills:

• Previous experience in quality management system (QMS) management is required.
• Previous QA experience within GCP/GCLP late-stage development environments is required.
• Experience with and strong knowledge of GCP/GCLP regulations, Good Documentation Practices, ALCOA+, and data integrity principles are required.
• Experience with electronic document management systems is required.
• Experience with Microsoft Word, EXCEL, PowerPoint is required.
• Experience in the creation of training materials, process flow diagrams (e.g. Lucidchart) and presentations is required.
• Experience with late stage (Phases 2b-3) clinical development highly preferred.
• Experience with the use and administration of Veeva QualityDocs and UL ComplianceWire is preferred.
• Exhibits a supportive, empathetic and patient approach to effectively coach and support system end users across multiple units in a global virtual work environment.
• Possesses strong analytical and problem-solving skills.
• Ability to manage multiple priorities with minimal supervision.