Donor Services Manager - Donor Services Review

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.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.

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