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 08:00 AM - 05:00 PM
Exempt / Non-Exempt: Exempt

Purpose:

The Donor Services Manager is responsible for managing the HCT/P donor eligibility review process.

 

Duties & Responsibilities:

  • Develop and maintain professional working relationships with recovery/acquisition agencies.
  • Manage performance feedback with recovery/acquisition agencies.
  • Manage processes and efficiency in department to support organizational strategic objectives.
  • Manage and oversee HCT/P donor eligibility record review to support production activities.
  • Evaluate and report donor review quality metrics.
  • Support risk management of department and ensure risks/issues are identified, addressed/reported, and where appropriate, escalated.
  • Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
  • Initiate and investigate quality events and determine appropriate containment, preventive/corrective actions.
  • Provide quality oversight, support, and approval for new projects and products.
  • Collaborate with Product Development/Management to establish/support project timelines.
  • Support internal and external audits.
  • Maintain records in accordance with standard operating procedures.
  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, cGMP/CGTP, and other organizational policies and procedures.
  • Manage direct reports.
  • Establish and monitor objective annual goals for direct reports.
  • Conduct performance reviews and establish performance improvement plans as needed.
  • Establish and execute continuing education strategy for department.
  • Recruit, interview, and select personnel for hire.
  • Travel domestically up to 15% to attend offsite meetings, conferences, and support business initiatives.
  • Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments.
  • Perform other related duties as assigned.

 

Skills & Abilities:

  • Strong leadership skills.
  • Attention to detail skills.
  • Organizational skills.
  • Critical Thinking skills.
  • Excellent verbal and written communication skills.
  • Proficient in Microsoft Office
  • Ability to secure and maintain a favorable background investigation and clearance.

 

Education & Experience:

  • Bachelor’s degree in a biological science or related field is required.
  • At least 5 years of quality and/or HCT/P review experience in an FDA regulated environment.
  • Valid Class “C” driver\'s license.