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.