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Director, Donor Quality

Ossium Health

Ossium Health

Quality Assurance
Indianapolis, IN, USA
Posted on Tuesday, November 21, 2023
Ossium’s mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood and immune diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.

About the Job

We’re hiring an organ/tissue donation quality expert who can help Ossium streamline our chart clearing process. The Director, Donor Quality Assurance (DQA), will create systems that allow proactive identification of missing and incorrect documents, track the flow of documents, and ensure everyone on the team is set up for success.

You will oversee a team of Quality Assurance Specialists tasked with rapidly and accurately reviewing charts and ensuring all necessary data is present and correct. Working closely with the Medical Director, you will facilitate the prompt release of carefully reviewed, high quality donors. You will report directly to the Chief Science Officer.

Required Qualifications

  • Bachelor's degree
  • 8+ years of Quality Assurance experience, with a focus on donor record review, at an organ procurement organization, tissue recovery agency, or tissue processor
  • 4+ years of people management experience
  • Experience in Quality Management Systems and proven effective operation in a GTP, GMP, and/or CLIA compliant operation
  • Experience with AATB standards
  • Outstanding project management skills and attention to detail
  • Experience building relationships and working closely and constructively with outside groups
  • Excellent written and oral communication skills
  • Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
  • This position is based full time in our Indianapolis facility

Preferred Qualifications

  • A BS or BA in biological sciences or related field
  • Demonstrated experience clearing chart backlog

Key Responsibilities

  • Collaborate with senior leadership to establish and define goals, objectives, and operational plans that support the goals and objectives of the organization
  • Oversee Donor Quality Assurance (DQA) activities and ensure projects and departmental goals are being met
  • Supervise operation of and monitor quality metrics pertaining to donor status, chart release, pending items, recovery partner audits, and recovery partner quality performance
  • Manage recovery partner qualification program
  • Remain current on standards and regulations and ensure methods, procedures, and systems comply
  • Recommend and author new or improved methods, procedures, and systems
  • Investigate non-conformances and recommend corrective actions related to donor quality
  • Analyze workflow and recommend methods for effective and efficient operation

In your first six months some projects you’ll work on include:

  • Clearing the existing backlog of donor records
  • Improving the efficiency of the DQA unit to ensure staff members are able to clear 2 or more charts per day
  • Significantly reducing time to obtain records from partners
  • Working directly with recovery partners to streamline communications and reduce the need for requested corrections

We offer a full slate of employee benefits including:

  • Competitive salaries
  • Stock options
  • 401(k) matching
  • Medical, dental and vision coverage
  • Four weeks of PTO accrued (vacation & sick time) annually + 11 company holidays
  • Employer paid life insurance and long term disability
  • Gym membership/recreational sports reimbursements
Ossium provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity or gender expression. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.