Job Details

VisionGift is a non-profit organization founded in 1975, we're dedicated to providing ocular tissue for transplants, research, and medical education. Since our inception, we've enabled over 65,000 people to receive the priceless gift of sight through the tissues we procure and screen. Our work not only supports transplant surgeons but also advances vital research projects and surgical training. Discover more about our mission and impact at www.visiongift.org VisionGift has an exciting opportunity for a Quality Program Manager (QPM). The QPM is responsible for overseeing and leading the daily activities of the VisionGift quality program, including delegating responsibilities to Quality Program Specialists. The QPM participates in and leads system and process improvement projects. This is a full-time, FLSA-exempt position. Location: We have a strong preference for a hybrid schedule for candidates located near our Portland, OR or Boston, MA offices. Candidates based outside these areas who reside in Washington, Minnesota, New Jersey, or Idaho will follow a quarterly travel schedule to support onsite collaboration, team connection, and organizational alignment. Essential Functions/Assigned Responsibilities and Duties: Establish a quality system that incorporates regulatory compliance and the principles of continuous improvement Ensure the requirements of the VisionGift quality program, as spelled out in SOP, are complete (e.g., document control program, internal audit program, adverse reaction reporting) Function as main contact for Regulatory Agencies, Departments of Health and other quality related communications. Acts as the lead for inspections by FDA and EBAA, customer audits, etc. This includes preparation of pre-inspection materials. Advise on compliance questions for SOP revisions, operational program changes, and software validation projects to ensure VG is making appropriate regulatory decisions. Provide coaching and development to Quality Program Specialist (QPS) including performance reviews and regular 1-on-1 meetings. Perform and assign duties to Senior Quality Program Specialist (SrQPS) and QPS, as necessary, to ensure smooth functioning of the VisionGift Quality Department. Define VisionGift internal audit schedule and confirm audits and corrections are completed on time as determined by SOP for all VG locations. Manage CAPA and departure from procedure (DFP) activities, including biologic deviation reporting to FDA, EBAA and consignees. Oversee document control program. Prepare VisionGift quarterly audit reports to be reviewed by senior management and Medical Director(s). Be able to perform all duties of Sr Quality Program Specialist and Quality Program Specialist , as needed. Be available to staff to assist with compliance and quality questions or problems. Maintain a professional demeanor and interact well with others. Some travel required for attendance of meetings and facility site visits. Compensation details: 68000-95000 Yearly Salary PI4c0e527e23e9-25448-40548264a25371ca-cde7-4fb6-ba87-2cf40b156c8b