Location: IAVI Headquarters, New York, New York, USA
Reports to: Director Laboratory Quality Assurance
The QA Manager is responsible for the physical and electronic management and administration of regulated and controlled documents and records for the Quality Assurance Department. The Quality Manager will also be expected to provide administrative management and support to Quality processes for but not restricted to deviation, CAPA and audit management. This role will participate in IAVI Quality-related management initiatives including Enterprise Risk Management (ERM) and Quality Assurance Committee (QAC) meetings
The QA Manager should have a solid understanding of quality systems and their relationship to GxP. The incumbent should also be able to communicate, coach, troubleshoot and train Veeva users.
User management and support
Maintenance of the Veeva System configuration including vaults, lifecycles, roles and routes.User Training
Participate in the development of training programs and ensure training records are readily available
Support the electronic Quality Management System
Maintain the document taxonomies for the electronic Quality Management System
Provide basic training and user support for the electronic Quality Management System
Administer, support and further develop, implement, continuously improve and manage the Quality Management System including but not limited to the provision of reports for management review, including quality metrics
Coordinate the review, approval, issue and maintenance of GxP controlled documents.
Provide input, support in the development of core Quality Policies and QA processes including: Standard Operating Procedures, Training, Exceptions-Investigations and Corrective and Preventative Actions as well as the maintenance of the above.
Be part of the review and approval cycle as it pertains to the quality aspect for SOPs, SLMs, Validation documents and other controlled documents as QA responsible
Assist with maintaining Quality System logs and database and track closure activities
Manage electronic change requests
Manage the flow of Regulatory and Controlled documents into and out of document storage and oversee offsite storage and backup systems and maintain document archives both physically and electronically
Improve the quality culture and promote quality awareness through training, mentoring and participation in teams and task forces.
QA Department Budget and External Contract Management
Bachelor’s degree in Science preferred.
Technical/Scientific Writing and Document Formatting
Excellent Working Knowledge of Microsoft Office Applications (e.g. WORD, EXCEL, PowerPoint, Project, Adobe Acrobat Pro)Minimum 5-8 years’ experience in the healthcare industry in a quality role
Practical experience in the maintenance and administration of key Quality Systems required.
Working knowledge of GMP/GCP/GLP Validation (including Computer System Validation) and Quality Auditing
Familiar with the principles of document management, change control and Exception Management and CAPAs.
Familiar with local and national health, safety and environmental regulations
Prior experience in Quality Assurance within the Research/Vaccine/Biologics industry and experience of working within a clinical or diagnostic laboratory will also be considered.
Prior experience with electronic Document Management Systems and /or a Laboratory Information Management Systems (LIMS).
Experience with writing and or reviewing investigation reports, technical reports, bioanalytical method validation protocols and final reports, and equipment qualification protocols and final reports
Detail orientated with the ability to identify and communicate potential problems
Ability to function effectively in a complex work environment and deal effectively with numerous simultaneous requirements
Ability to work independently as well as a team player
Must be a patient and good communicator who can function in an organizational environment involving a diversity of cultures, languages and personal interests and agendas
Excellent interpersonal skills
Excellent written and verbal communication skills in the English language.
Excellent attention to detail
Project management skills
About International AIDS Vaccine Initiative IAVI
The International AIDS Vaccine Initiative (IAVI) is a nonprofit scientific organization founded in 1996 whose mission is to develop HIV vaccines for use throughout the world. IAVI is playing an important role in the HIV vaccine field by undertaking leading-edge research and development of novel vaccine candidates; establishing end-to-end product development pathways for HIV vaccine and prevention modalities that incorporate understanding of the needs of at-risk communities and end-users; and bringing new capabilities and innovation to the field through novel collaborations and partnerships to accelerate product development. In addition to its core HIV vaccine effort, IAVI is expanding its R&D to address other urgent unmet medical needs – such as vaccines for other infectious diseases – affecting communities most at risk of HIV infection.
IAVI Core Values:
Dedication to the Mission: We are committed to the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world to achieve a world without AIDS
Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes a...nd never giving up
Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
Collaboration: We are committed to embracing diversity, the power of glocal teamwork and the belief that by working as one we can make a difference