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.