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.

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions • Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines • Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits • Prepares and maintains site manuals, reference tools and other documents • Maintains, updates, and inputs clinical tracking information into databases • Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client • Manages shared mailbox, processes site requests and routes correspondence appropriately • Coordinates the ordering, packaging, shipping and tracking of site supplies and materials • Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items • May handle receipt, tracking and disposition of Case Report Forms and Queries • Maintains overall awareness in the field of clinical research by completing all necessary and assigned training

• Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge. • Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specified studies • Provide input into global subject/patient recruitment plans. • Relationship management between study sites and vendors • Manage aspects of CRO/vendor identification and the day to day operational management activities of CROs & other vendors including set up, statement of work creation and budget oversight. • Manage strategic study operations including: study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc. • Create and update critical trial-specific documents (for example country specific ICF) and plans • Support development of compound and protocol level training materials • Review and provide input into budgets, timelines, and forecasts for assigned clinical studies • Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Clinical Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups. • Provide support for inspection readiness activities and on identification of risks and mitigation plans at the trial level • Participate in process improvement activities at a trial and department level as needed • Support onboarding of new team members • Attend CTWG and provide input and updates on operational activities and progress • Ability to travel (approximately10% but flexibility to go over or below as per business need.