Donor Services Manager

Position Title: Donor Services Manager
Department: Donor Services Review
Reports To: Head of Donor Services Review
Job Type: Full Time
Shift: Monday - Friday 08:30 AM - 05:00 PM
Exempt / Non-Exempt: Exempt

Purpose:

As the Donor Services Manager, you will be the key driver ensuring our donor eligibility process meets the highest standards, directly impacting life-saving tissue donations. Your work will play a vital role in transforming patient outcomes and enhancing the quality of our donor services.

 

Duties & Responsibilities:

  • Lead and foster professional relationships with recovery/acquisition agencies to ensure smooth, efficient collaboration.
  • Drive performance feedback processes with recovery/acquisition agencies, ensuring continuous improvement.
  • Optimize departmental processes to support the organization\'s strategic objectives.
  • Oversee and ensure compliance with the HCT/P donor eligibility record review to support production activities.
  • Evaluate and report donor review quality metrics to track and improve performance.
  • Manage risk within the department by identifying, addressing, and escalating risks/issues as appropriate.
  • Author and revise procedures in alignment with FDA, AATB, and other regulatory standards, ensuring up-to-date compliance.
  • Initiate and investigate quality events, determining appropriate containment and corrective actions.
  • Provide oversight and approval for new projects and products, ensuring quality at every stage.
  • Collaborate with Product Development/Management teams to establish and maintain project timelines.
  • Support internal and external audits to ensure ongoing regulatory compliance.
  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, cGMP/CGTP, and other organizational policies and procedures.
  • Maintain records according to SOPs, ensuring data accuracy and availability.
  • Develop and lead your team, establishing annual goals and conducting performance reviews to foster professional growth.
  • Design and execute a continuing education strategy to ensure your team stays at the forefront of industry knowledge and regulatory changes.
  • Recruit, interview, and hire new personnel to build a strong, capable team.
  • Travel up to 15% to attend offsite meetings, conferences, and support business initiatives.
  • Ensure compliance with scheduled timelines and meeting attendance.
  • Perform other related duties as assigned.

 

Skills and Abilities:

  • Strong leadership with a demonstrated ability to drive team performance and optimize processes.
  • Detail-oriented with excellent organizational and critical thinking skills.
  • Outstanding communication, both verbal and written.
  • Proficient in Microsoft Office and ability to work with complex data sets.
  • Ability to maintain favorable background investigation and security clearance.

 

Education & Experience:

  • Bachelor\'s degree in biological sciences or related field required.
  • 5+ years of quality or HCT/P review experience within an FDA-regulated environment.
  • Demonstrated expertise in ensuring compliance with FDA and AATB standards, with a proven track record of optimizing team and process performance.
  • Valid Class “C” driver’s license.