Job Title: Donor Services Manager
Location: San Antonio, TX
Salary: $85K - $120K plus 15% bonus
About the Company / Opportunity:
As the Donor Services Manager, you will play a key role in a mission-driven organization, ensuring that our donor eligibility process adheres to the highest standards. Your work will directly support tissue donations and significantly impact patient outcomes. This is an opportunity to lead a team, foster collaboration with recovery/acquisition agencies, and ensure compliance with industry regulations, all while optimizing processes for success.
Responsibilities:
- Work with recovery agencies to ensure efficient collaboration.
- Oversee and optimize performance feedback processes for continuous improvement.
- Manage compliance with HCT/P donor eligibility record reviews and support production activities.
- Track, evaluate, and report donor review quality metrics.
- Identify and address risks within the department, escalating issues when necessary.
- Author and revise procedures to comply with FDA, AATB, and other regulatory standards.
- Initiate investigations into quality events and take corrective actions.
- Provide oversight for new projects and ensure quality at every stage.
- Collaborate with Product Development/Management teams to maintain project timelines.
- Support internal and external audits for regulatory compliance.
- Ensure accurate record-keeping according to SOPs.
- Develop and manage a high-performing team, conducting annual reviews and goal-setting.
- Lead the hiring process for new personnel.
- Design and implement continuing education strategies for the team.
- Travel up to 15% as needed.
Must-Have Skills:
- Bachelor’s degree in biology or a related field.
- 5+ years of experience in quality or HCT/P review within an FDA-regulated environment.
- Knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, cGMP/CGTP.
- Strong leadership and team management skills.
- Valid Class "C" driver’s license.
Nice-to-Have Skills:
- Experience collaborating with internal teams.
- Prior experience overseeing new product or project launches.
- Familiarity with risk management and quality event investigations.
- Previous experience with internal/external audit processes.
