Cordova, TN, 38088, USA
10 hours ago
Tissue Program Manager
Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. Tissue Program Manager is responsible for the efficient and compliant management of the Tissue Recovery and Donor Service Department at the BioDlogics / Integra LifeSciences - Memphis human tissue manufacturing facility. This role will lead a team in highly specialized, rapidly growing human tissue processing facility where raw materials are acquired from participating hospitals and third-party donor recovery partners. The Tissue Program Manager will provide leadership and direction ensuring compliance with Integra policies and procedures, the standards and regulations as outlined by the FDA, ISO, AATB, and other applicable federal, state and local laws. **RESPONSIBILITIES** + Provides leadership, coaching and mentorship to Tissue Recovery and Donor Service staff. + Ensures the Tissue Recovery and Donor Service staff meet on regular basis and follow up with staff pertaining to performance concerns. + Ensures Tissue Recovery staff are performing the required day-to-day task necessary to run operations such as but not limited to staffing actives, workload allocation and tissue recovery activities, training, chart review, and auditing of recovery functions. + Provides technical and clinical advice to staff pertaining to the donor screening, procedural clarification, recovery, and serves as the administrator on call. Consults with multi-tissue medical directors as needed to qualify the donor for recovery. + Sets expectations, sets the standard for professionalism, and holds staff accountable to expectations and goals. + Responsible for the maximization of tissues recovered per donor to ensure tissue processors requirements are met. + Prepares reports and analyzes data as requested by leadership to inform management, suggest process improvements to meet goals, or provide data on programs and services. + Ensures staff understand and comply with all recovery objectives, performance standards, and policies. + Executes individual, departmental and organization goals and objectives. + Maintains competency and skill set to perform tissue recoveries and donor screening. + Complies with current Good Manufacturing Practices and all applicable standards and regulations. + Actively support the quality system by participating in internal audits, reviewing quality documentation, and contributing to continuous improvement. + Any other duties or responsibilities necessary or as assigned. + Recognize and solve problems that can occur in own work area without supervisory approval. + Log donors into all applicable databases. All databases/logs MUST always be current. **REQUIRED QUALIFICATIONS** + Required bachelor's degree in science, Engineering, or related discipline with 8+ years of experience leading a team (direct reports). Or master's degree in science, Engineering, or related discipline with 6+ years of experience leading a team (direct reports). + Experience with External Regulatory Agency audits (i.e., Notified Bodies and FDA). + Certified Tissue Bank Specialist (CTBS) preferred (willing to obtain within the first year and maintained throughout employment). + Experience in Compliance and Tissue Banking preferred + Excellent leadership skills with a team-focused attitude. + Demonstrated organizational and analytical skills. + Strong communication skills, both written and verbal. + Ability to work with moderate supervision and guidance. + Strong understanding of quality principles, techniques, and relevant regulatory requirements (FDA, ISO) within medical device or regulated industry. + Clear and concise communication with production personnel, quality assurance team, and other stakeholders regarding quality concerns and findings. + Precise and accurate recordkeeping, including completing detailed inspection reports and maintaining proper documentation according to established procedures. Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada\_veterans\_employers.cfm) Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666. Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
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