Quality Program Manager (Hybrid)

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.

Education: Bachelor’s degree in science is preferred. Experience in medical/healthcare field may

substitute for science-related degree.

Experience/Skills:

• 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. Familiar with Ideagen (Q-Pulse) QMS, Viewlinc, and iMonnit software preferred.
• Willingness to continue and advance knowledge in quality systems (i.e. attaining certification, attend seminars, online classes, etc.).

  VisionGift offers a generous benefit package including but not limited to: 

• Employer paid medical and vision plan with a buy up option
• Dental benefits for $10 a month
• $20,000 employer-paid life insurance policy
• Employer-paid short-term disability
• Voluntary benefits such as Dependent Care and FSA 
• 401k with employer match
• 7 paid holidays, 1 DEI holiday and 1 floating holiday
• 3 weeks PTO to in the first year which increases to 6 weeks with tenure
• Sabbatical leave every 5 years
• Paid parental leave and more!

Range:  $68,000.00-$95,000.00/annum 

NOTICE TO APPLICANTS:

Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet 100% of the qualifications listed in the job post. We are more interested in finding the best candidate for the job, and encourage you to apply, even if you do not meet every qualification listed. If you are unsure if you meet the qualifications of this role please email [email protected] to discuss your application. 

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