Quality Program Manager (Hybrid)

VisionGift•Washington, OR

1d•Hybrid

About The Position

VisionGift is a non-profit organization founded in 1975, dedicated to providing ocular tissue for transplants, research, and medical education. Since its inception, VisionGift has enabled over 65,000 people to receive the gift of sight through procured and screened tissues. The organization supports transplant surgeons, advances vital research, and facilitates surgical training. This is a full-time, FLSA-exempt position with a hybrid work schedule preference for candidates near Portland, OR or Boston, MA offices. Candidates outside these areas in Washington, Minnesota, New Jersey, or Idaho will have a quarterly travel schedule for onsite collaboration.

Requirements

Bachelor’s degree in science is preferred. Experience in medical/healthcare field may substitute for a science-related degree.
3+ years of management or supervisory experience preferred.
2 years of experience on the VG Quality Assurance team, or 3+ years working with Quality Systems in eye, tissue, blood banking, or related field.
Experience with CAPA structures and root cause analysis.
Experience with process, compliance, and department audits.
Experience with 2nd and 3rd party audits, especially EBAA and FDA inspections.
Fluent in EBAA Medical Standards and FDA CGTPs.
Excellent attention to detail, and writing and communication skills.
Strong analytical, critical thinking, and problem-solving skills.
Strong leadership and organizational skills.
Reliable and timely decision maker.
Proficient PC application skills, including knowledge of Microsoft Office package required.
Willingness to continue and advance knowledge in quality systems (i.e. attaining certification, attend seminars, online classes, etc.).

Nice To Haves

Familiar with Ideagen (Q-Pulse) QMS, Viewlinc, and iMonnit software preferred.

Responsibilities

Oversee and lead the daily activities of the VisionGift quality program, including delegating responsibilities to Quality Program Specialists.
Participate in and lead system and process improvement projects.
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 the main contact for Regulatory Agencies, Departments of Health, and other quality-related communications.
Act as the lead for inspections by FDA and EBAA, customer audits, etc., including preparation of pre-inspection materials.
Advise on compliance questions for SOP revisions, operational program changes, and software validation projects to ensure appropriate regulatory decisions are made.
Provide coaching and development to Quality Program Specialists, including performance reviews and regular 1-on-1 meetings.
Perform and assign duties to Senior Quality Program Specialists and Quality Program Specialists, as necessary, to ensure smooth functioning of the VisionGift Quality Department.
Define the 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 the document control program.
Prepare VisionGift quarterly audit reports for review by senior management and Medical Director(s).
Be able to perform all duties of Senior 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.
Travel may be required for attendance of meetings and facility site visits.