Quality Assurance Manager Jobs

IF YOU ARE LOCATED IN NYC OR NJ THIS ROLE IS A HYBRID

Must Have GLP Experience

Company: IAVI

Location: Remote

Title: GLP Quality Assurance Manager

:

IAVI is seeking an experienced GLP Quality Assurance Manager who is eager to help translate science, into global health impact! The GLP QA Manager candidate will have a thorough understanding of GLP compliance, and lead the development, maintenance, and continuous improvement of IAVI’s GLP Quality Assurance Program. This experienced GLP Quality Assurance expert provides guidance and support, ensuring GLP compliance in an effective and efficient way.”

Key Responsibilities:

Operational Activities:

• Mentor and provide guidance to junior QA colleagues across IAVI.
• Review agreements (e.g. MSAs with CROs,) for GLP Quality Assurance inputs required for the execution of agreements.
• Assist in the development, approval, and maintenance, and management of agreements (e.g. confidential disclosure agreements, RFPs, Consulting Agreements, MSAs, quality agreements, etc).

GLP Quality Assurance Activities:

• Provide recommendations and guidance on GLP requirements to Internal Project teams.
• Compile documentation in preparation for the audit.
• Coordinate the use of continuous improvement of the electronic quality management system (eQMS).
• Inspect and audit nonclinical laboratory safety studies to assure quality and compliance with Good Laboratory Practice (GLP) and other applicable regulations and departmental procedure.
• Review study protocols, amendments, and deviations.
• Review audited final reports and raw data from external vendors (e.g., contract research organizations).
• Work with departmental management and program/project team directors to establish work plans (including GANTT Charts) related to GLP Quality Assurance activities.
• Conduct inspections and audits of studies or portions of studies conducted by IAVI.
• Development of GLP Quality Assurance related SOPs.
• Prepare clearly written, accurate, and evidence-based audit reports to effectively communicate the audit findings to the auditees and management.
• Review and assess corrective action plans and follow-up on the resolution of audit findings.
• Perform GLP systems audits at contract research organizations, for the purpose of assessing regulatory compliance.
• Review method development, method validation, and safety study data.

Education and Work Experience:

· Bachelor’s Degree in a life sciences or related field; advanced degree desirable;

· 5 years of experience in GLP Quality Assurance or related role or function.

Qualifications and Skills:

• Excellent interpersonal skills, including written and oral communication skills are highly desirable.
• RQAP-GLP credentials preferred.
• Experience with Animal Rule studies desirable
• Experience in biologics and / or vaccines is highly desirable
• Experience with data integrity required.
• Ability to travel up to 30% required.
• Strong working knowledge and experience with of Microsoft Office Applications (Word, Excel, Powerpoint, Project) highly desirable.
• Experience managing and conducting GLP audits required.