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Donor Services Manager
4 months ago
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.