PURPOSE AND SCOPE: The Clinical Quality Manager is responsible for developing, implementing, and monitoring quality assurance and performance improvement (QAPI) programs to ensure the highest standards of patient care and regulatory compliance. This role oversees clinical outcomes, coordinates quality initiatives, ensures adherence to regulations, and collaborates with the interdisciplinary team to drive continuous improvement in patient safety and clinical quality performance. The scope of the clinical quality oversight of the position covers assigned treatment modalities (e.g. in-center, home modalities, or home hemodialysis and home peritoneal dialysis) PRINCIPAL DUTIES AND RESPONSIBILITIES: - Lead or participate in the clinic’s Quality Assessment and Performance Improvement (QAPI) program in alignment with CMS, state, and organizational standards. - Develop and implement action plans to address deficiencies and improve care delivery. - Conduct regular audits and quality reviews to ensure compliance with clinical policies & procedures. - Facilitate staff education and training related to quality improvement, patient safety, and best practices. - Collaborate with physicians, nurses, dietitians, social workers, and leadership to support evidence-based clinical initiatives. - Prepare and present quality reports to clinic leadership and governing bodies. - Ensure accurate documentation, data collection, and reporting for internal and external stakeholders. - Promote a culture of accountability, safety, and continuous improvement within the clinic. - Manages the execution and achievement of Quality key performance indicators (assigned by Quality leadership team) and other clinical initiatives, interventions and standardized education materials with clinic teams within the assigned area(s). - Performs other related duties as assigned. PHYSICAL DEMANDS AND WORKING CONDITIONS: - The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. - Day-to-day work includes desk and personal computer work and interaction with facility staff and physicians. - The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials. - Field: The position requires travel between assigned facilities and various locations within the community, approx. 60%-80%. ○ Travel to Regional, Division and Corporate meetings may be required. - Remote: The position could require travel up to 10-15% SUPERVISION: - None EDUCATION AND REQUIRED CREDENTIALS: - Registered Nurse required - BSN or bachelor’s degree in healthcare-related field preferred (or equivalent experience). - Certification in Nephrology Nursing or quality preferred EXPERIENCE AND SKILLS: - 3+ years of dialysis experience required. - 2+ years' experience in a leadership role. - Strong organizational, critical thinking and customer service skills. - Demonstrated leadership competencies and adaptability to changes in priorities - Ability to work collaboratively with other members of the team, gain support and input while participating in quality improvement activities. - Strong verbal and written communications skills. - Ability to analyze and propose alternate solutions, assist in resolving sensitive to complex issues Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors

PURPOSE AND SCOPE: Develops, implements, maintains and evaluates an effective, data-driven, quality assessment and performance improvement program(s) with participation by other members of the interdisciplinary team. Serves as a quality improvement champion and role model by promoting and supporting the use of Continuous Quality Improvement (CQI) principles, methods, and tools to improve processes and patient outcomes at the facility and area levels. Must have effective communications among the interdisciplinary team (IDT) and must produce effective quality assessment and performance improvement activities which positively influence the assigned dialysis clinics clinical quality outcomes. The scope of the clinical quality oversight of the position covers all treatment modalities (e.g. in-center, home hemodialysis and home peritoneal dialysis), and in collaboration with the IDT, is responsible for the monitoring data/information; prioritizing areas for improvement; determining potential root causes; developing, implementing, evaluating, and revising plans that result in improvements in clinical quality outcomes in dialysis facilities within a geography. PRINCIPAL DUTIES AND RESPONSIBILITIES: - Facilitates the implementation and integration of the FKC Quality programs and initiatives into the facilities' standard operating procedures through teamwork and collaboration with area and facility clinical, interdisciplinary and operations teams. - Serves as a subject matter expert for clinical quality matters when collaborating with other RNs and members of the Area Quality Team. Identifies clinical quality improvement opportunities in the assigned area to achieve CMS Conditions for Coverage and FMS quality program requirements. - Manages the tactical execution of Quality and other clinical initiatives, interventions and standardized education materials with facility RNs within the assigned area. - Provides general direction, nursing and clinical guidance related to appropriate theoretical perspectives and feedback based upon professional standards and FMCNA guidelines to support facility RNs within the assigned area in achieving the desired outcomes in the following: quality, patient satisfaction, teamwork, unit culture, and employee satisfaction. - Collaborates with appropriate stakeholders including but not limited to the Clinical Quality leadership, Education, Clinical Services, Regulatory and Compliance to take the appropriate steps to facilitate achievement of quality goals and ongoing patient safety improvement. - Mentors and trains staff to collect, trend, and analyze data on a day to day basis to monitor the effectiveness of their clinical and operational processes to impact patient centered care resulting in improved patient outcomes and satisfaction and decreased morbidity and mortality. - Utilizes evidenced based and best demonstrated practices to address barriers to quality improvement. This includes promoting the adoption and utilization of Corporate Medical Advisory Board Recommended Algorithms and Standing Orders, clinical pathways and clinical policies and procedures to improve care coordination and care delivery. - Leverages available tools, resources and informatics technology to focus on targeted patient populations. - Applies current knowledge of FMS clinical and administrative policies and procedures, available internal resources, working knowledge of CMS Conditions of Coverage for ESRD facilities, Value Based Payer Programs, knowledge of quality improvement concepts, principles and practices to perform tasks and duties. - Utilizes quality improvement techniques to promote collaboration between facilities and areas to share processes and strategies for success. Mentors and assists facilities in identifying effective practices applicable to their needs, in testing for desired results, and the adoption and implementation of these practices. - Under the direction of Clinical Quality leadership, provides guidance, interpretation and subject matter expertise to clinical and operations teams regarding quality related clinical policies and procedures, clinical standards, quality improvement tools and electronic applications. - Performs desk review of facility Quality Assessment and Performance Improvement (QAPI) documentation and attends QAPI meetings at a frequency determined by Clinical Quality leadership. Collaborates with facility management staff to evaluate the effectiveness of the facility QAPI Program and CQI activities utilizing the following processes. - Reviews completion of facility QAI activities including but not limited to adherence to the QAI calendar, completion of QAI tools and electronic applications - Attends and participates in regional, area, facility and team meetings as appropriate which may include quality team building and staff development and other meetings as appropriate. Collaborates with appropriate management staff as needed to achieve effective inter-disciplinary, intra-disciplinary and clinic relationships. - Identifies risk areas and opportunities for improvement. - Assists with root cause analysis and action plan development and evaluation as needed. - Provides written or verbal recommendations to facility and area management. - Utilizes adult education principles in the execution of education programs and processes that facilitate the implementation and incorporation of the company's quality standards and the practice of Continuous Quality Improvement in facility standard procedures. - Accountable for outstanding customer service to all external and internal customers, including patients, staff, physicians, field management and staff, and payers, including disease management entities. - Develops and maintains exceptional working relationships through effective and timely communication with all customers - Under the direction of Clinical Quality leadership, assists with various projects as assigned. - Performs other related duties as assigned. PHYSICAL DEMANDS AND WORKING CONDITIONS: - The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - Day to day work includes desk and personal computer work and interaction with facility staff and physicians. - The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials. - The position requires travel between assigned facilities and various locations within the community, approx.. 40-60%. Travel to Regional, Division and Corporate meetings may be required SUPERVISION: - None EDUCATION AND REQUIRED CREDENTIALS: - BSN or Bachelor's Degree in healthcare related field preferred or an equivalent combination of education and experience - Registered Nurse required - Certification in Nephrology Nursing or quality preferred. EXPERIENCE AND SKILLS: - 3+ years dialysis experience required - 3+ years management experience in a clinical leadership role - Strong organizational, critical thinking and customer service skills - Demonstrated leadership competencies and adaptability to changes in priorities - Ability to work collaboratively with other members of the team, gain support and input while participating in quality improvement activities - Strong verbal and written communications skills, - Ability to analyze and propose alternate solutions, assist in resolving sensitive to complex issues Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws. Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors

PURPOSE AND SCOPE: The Clinical Quality Manager is responsible for developing, implementing, and monitoring quality assurance and performance improvement (QAPI) programs to ensure the highest standards of patient care and regulatory compliance. This role oversees clinical outcomes, coordinates quality initiatives, ensures adherence to regulations, and collaborates with the interdisciplinary team to drive continuous improvement in patient safety and clinical quality performance. The scope of the clinical quality oversight of the position covers assigned treatment modalities (e.g. in-center, home modalities, or home hemodialysis and home peritoneal dialysis) PRINCIPAL DUTIES AND RESPONSIBILITIES: - Lead or participate in the clinic’s Quality Assessment and Performance Improvement (QAPI) program in alignment with CMS, state, and organizational standards. - Develop and implement action plans to address deficiencies and improve care delivery. - Conduct regular audits and quality reviews to ensure compliance with clinical policies & procedures. - Facilitate staff education and training related to quality improvement, patient safety, and best practices. - Collaborate with physicians, nurses, dietitians, social workers, and leadership to support evidence-based clinical initiatives. - Prepare and present quality reports to clinic leadership and governing bodies. - Ensure accurate documentation, data collection, and reporting for internal and external stakeholders. - Promote a culture of accountability, safety, and continuous improvement within the clinic. - Manages the execution and achievement of Quality key performance indicators (assigned by Quality leadership team) and other clinical initiatives, interventions and standardized education materials with clinic teams within the assigned area(s). - Performs other related duties as assigned. PHYSICAL DEMANDS AND WORKING CONDITIONS: - The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. - Day-to-day work includes desk and personal computer work and interaction with facility staff and physicians. - The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials. - Field: The position requires travel between assigned facilities and various locations within the community, approx. 60%-80%. ○ Travel to Regional, Division and Corporate meetings may be required. - Remote: The position could require travel up to 10-15% SUPERVISION: - None EDUCATION AND REQUIRED CREDENTIALS: - Registered Nurse required - BSN or bachelor’s degree in healthcare-related field preferred (or equivalent experience). - Certification in Nephrology Nursing or quality preferred EXPERIENCE AND SKILLS: - 3+ years of dialysis experience required. - 2+ years' experience in a leadership role. - Strong organizational, critical thinking and customer service skills. - Demonstrated leadership competencies and adaptability to changes in priorities - Ability to work collaboratively with other members of the team, gain support and input while participating in quality improvement activities. - Strong verbal and written communications skills. - Ability to analyze and propose alternate solutions, assist in resolving sensitive to complex issues If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave. Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors

Role Description Sr Manager of Clinical Supply Operations is responsible for investigational material activities for Phase I-IV assigned studies within Mylan Clinical Operations, including coordination of packaging, labelling, and distribution at Contract Packaging Vendors. This individual will collaborate with medical, regulatory, and clinical experts/personnel to ensure that quality Clinical Supplies are provided according to departmental SOPs and applicable regulations. This position also interacts with both internal and external supply chain and logistics personnel in the procurement of clinical drug supplies. Every day, we rise to the challenge to make a difference and here’s how the Clinical Supply Operations Lead role will make an impact: - Serves as core team member for clinical projects representing investigational materials and/or technical operations. - Responsible for technical assessments, selection of contract packaging vendors to provide service for specific projects, review and approval of contracts, pack design, drug ordering, supply plan management for packaging and labelling activities conducted by clinical supply vendors and monitoring of budget. - Participates in audits and monitoring of clinical supplies vendors. - In conjunction with the clinical supply vendors and internal departments, coordinates QA/QP release of investigational materials to be used in global clinical trials. - Reviews and approves IVRS specifications from investigational materials perspective. - In conjunction with CRO and Regulatory, co-ordinates the design of clinical labels to meet protocol, FDA, EU and other country specific regulatory requirements. - Writes or reviews the Study Medication Sections of the protocol and IND as required. - In conjunction with clinical supply vendors, monitors Investigational Materials inventories and expiry/retest dates supplies. - Trains investigators and CROs on protocol procedures related to Investigational materials. - Creates, reviews, and revises Clinical Supply related SOPs as appropriate. - Perform other duties as assigned. Qualifications - Clinical Supplies knowledge with comprehensive operational experience in R&D Clinical Supplies and related areas on a global level. - Must possess advanced knowledge of project management, packaging, labelling and distribution of clinical studies. - Knowledge of and excellent understanding of Good Manufacturing Practice (GMP) and other associated regulations, guidelines, and industry standards for clinical trials. - Excellent interpersonal and communication skills. - Strong planning, organizational, and problem-solving skills. - B.S. Degree or related scientific discipline + 7 years pharmaceutical industry experience. - Thorough understanding of the development and clinical supplies process. - Ability to maintain accurate records and files in accordance with GMPs, SOPs, and other regulatory requirements. - Experience with e-mail, Windows, word-processing, database, spreadsheet applications as well as Microsoft Project and PowerPoint. - Strong decision-making, detail-oriented, multi-tasking, and negotiation skills. - Ability to work effectively in a multifunctional team environment. - Be flexible. Benefits - Top Employer Accreditation, demonstrating that we provide excellent people policies and practices. - Competitive compensation package inclusive of annual discretionary bonus and stock options. - Focus on career progression with growth and development opportunities. - Emphasis on Health & Wellness programmes. - 100% paid medical insurance and Employee Assistance Programme. - Life cover. - Excellent employer-matched pension scheme with Viatris contributing up to 11%. - 2 paid volunteer days per year.