Director, Laboratory Quality Assurance
The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective and accessible, preventive HIV vaccines for use throughout the world. Founded in 1996, IAVI works with partners in 25 countries to research, design and develop AIDS vaccine candidates. The organization also conducts policy analysis and serves as an advocate for the AIDS vaccine field. It supports a comprehensive approach to addressing HIV and AIDS that balances the expansion and strengthening of existing HIV prevention and treatment programs with targeted investments in the design and development of new tools to prevent HIV. IAVI is dedicated to ensuring that a future AIDS vaccine will be available and accessible to all who need it. The organization relies on the generous donations of governments, private individuals, corporations and foundations to carry out its mission.
Title: Director, Laboratory Quality Assurance
Location: IAVI Headquarters, New York, New York, USA
The Director, Laboratory Quality Assurance, plays a critical role in the development, maintenance and continuous improvement of IAVI Laboratory Quality Management Systems. The incumbent also serves as the head of quality assurance for IAVI’s laboratories and provides guidance and support to ensure that laboratory quality systems support compliance in an effective and efficient manner.
The Director of Laboratory Quality Assurance should have a solid understanding of laboratory quality systems and their relationship to GRP/GMP/GLP/GCP/GCLP. The incumbent should also be able to combine the scientific and technical aspects of quality assurance, manage projects and think critically.
Departmental Management Activities
- Assist in the Development, Maintenance and Management of the Budget for Quality Assurance (HQ870)
- Develop, Maintain and Continuously Improve IAVI Laboratory Policies, Standard Operating Procedures, Work Instructions, Templates and Other Required Documents
- Manage and Provide Oversight to the Work of Employees and/or Consultants Engaged in Laboratory Quality Systems/Assurance Operational Activities
- Assist in the Development, Approval and Maintenance of, and Manage, Agreements (e.g. Confidential Disclosure Agreements, Requests for Proposal, Consulting Agreements, Master Services Agreements, Quality Agreements, etc.) for Laboratory Quality Assurance
- Review Agreements (e.g. Master Services Agreements with CROs, CMOs, CTOs; Clinical Trial Agreements; etc.) for Laboratory-related Quality Assurance Inputs Required for the Execution of the Agreement
Program/Project Team Activities
Work with Departmental Management to Determine and Communicate Program/Project-Related Laboratory Quality Assurance Requirements to Program/Project Team Members and Partners
- Work with Departmental Management and Program/Project Team Directors to Establish Work Plans (Including Gantt Charts) Related to Laboratory Quality Assurance Activities
Quality Systems and Quality Assurance Activities
- Provide Quality Systems Guidance and Support
- Design and Development Laboratory, Brooklyn, New York, USA
- Method Development
- Pre-Clinical Safety
- Human Immunology Laboratory, London, England, UK
- Coordinate the Use and Continuous Improvement of the electronic Quality Management System (eQMS) in Relation to IAVI Laboratories
- Work with Document Control to Manage Document Life Cycle Using MasterControl®
- Provide Quality Assurance Guidance and Support for IAVI Laboratories
- Development of Laboratory-Related SOPs
- Pre-Qualification, Qualification, Routine and For-Cause Audits of Vendors/Suppliers, CROs and CTOs
- Quality Agreements
- Review and Approval of Standard Laboratory Methods, etc.
- Troubleshoot, Review and Approval of Deviations
- Review and Approve Validation Protocols and Studies (e.g. SLMs, Laboratory Equipment)
- Work with Laboratories to Resolve Deviations (e.g. Stability Failures, Clinical Holds, etc.)
- Research Regulations and Guidance Documents
- Keep Abreast of Changes to Global Regulations
- Provide Staff Training on Current and New Quality Requirements
- Participate in Professional Associations, Industry Groups, Etc.
- Member of IAVI’s Quality Assurance Committee
- Other Activities as Directed by Departmental Management
Knowledge, Skills and Experience
- Bachelor’s Degree in a Life Science -Related Subject
- Master’s Degree a Plus
- Knowledge of Statistics a Plus
- ASQ Certification(s) a Plus
- At Least 10 Years of Experience in Quality Systems Development / Quality Assurance
- Quality Manual, Policy and SOP Development
- Deviation Management
- Audit Management
- Experience in Biologics and/or Vaccines a Plus
- Excellent Interpersonal Skills
- Excellent Written and Oral Communication Skills
- Excellent Attention to Detail
- Project Management Skills
- Technical/Scientific Writing and Document Formatting
- Excellent Working Knowledge of Microsoft Office Applications (e.g. WORD, EXCEL, PowerPoint, Project)
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Specific lifting abilities required by this job include the ability to lift 25 lbs. from the floor to above the head.
- Specific vision abilities require by this job include close vision, distance vision, color vision, peripheral vision, depth perception and abilities to adjust focus.
The work environment characteristics described herein are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Traditional open-office environment (USA).
- Research and Development Laboratories, Manufacturing Facilities, Clinical Research Centers, Clinical Testing Laboratories
- Potential contact with chemicals, biological materials (including, but not limited to blood and infectious materials).
- Potential contact with laboratory animals and human volunteers.
- Local, domestic and international travel via automobile, tram/subway/train, ferry/boat/ship, and/or airplane.
IAVI is an equal opportunity employer and encourages applications from diversity candidates.
International AIDS Vaccine Initiative - 17 months ago