• Provides strategic and operational support within GMP Quality and Quality Systems • Leads training initiatives • Provides vendors management support • Drives process improvement • Partners cross-functionally to support successful Quality operations • Contributes to the continuous evolution of the CSV program, training management program, and strategy for improvement of cross-functional Quality Compliance • Supports day-to-day operational quality oversight for internal batch record review, batch disposition and manufacturing operations across the end-to-end manufacturing processes for the manufacture of clinical and commercial intermediates and drug product batches • Monitors operational activities and assesses continuous improvement within the QA operations • Serves as QA partner on change controls, CAPAs, deviations, OOS, and non-conformances • Facilitates root cause / A3 problem solving and partners with business partners on deviations/CAPAs (close on time, prove effectiveness) • Drafts, revises, reviews, and/or approves controlled documents including Standard Operating Procedures • Represents QA on cross-functional project teams and with external partners • Identifies and anticipates trends in quality issues; collaborates with leadership team to implement quality initiatives • Responsible for managing CSV oversite including planning and scheduling validation activities with external vendors • Ensures business partners assess and approve change controls for commercial processes for assessment of lot disposition processes • Identifies areas of improvement in training system performance, training process and overall training procedures • Manages training KPIs • Ensures business partners implement adequate training modules and learning activities • Contributes to the development, maintenance, and continuous improvement of SOPs, work instructions, and templates

• Manages and implements process improvement initiatives within their assigned projects. • The Consultant is the primary resource to project teams in support of all process improvement initiatives. • The Consultant will work with the project team and interact with the client to do process mapping, flow design, and analysis to identify process improvement requirements. • The Consultant will oversee the implementation of the process improvement recommendations with the client and work with other consultants to coordinate all facets of process improvement initiatives. • Develop Key Performance Indicators for the current state, and track KPIs during and after implementation of process improvement recommendations. • Mentor and coach team members on the fundamentals of business process modeling, Lean/Toyota Production System, Six Sigma, business process engineering, and similar areas of knowledge. • Develop new knowledge in process improvement to support our client initiatives.

• Organize and update physical and digital documents related to legal and administrative cases. • Scan, name and correctly file documents in internal and external systems. • Enter and update case information in legal systems (CPJ, PJe, Projudi, Eproc) and control spreadsheets. • Monitor administrative and judicial deadlines, ensuring compliance with internal schedules and SLAs. • Issue and request document protocols, initial filings, protests and various notifications. • Support the preparation of spreadsheets, reports and dashboards to track indicators and KPIs. • Request payments for court fees, protocols and other expenses related to case processing. • Assist the legal team with calculations, diligences and requests to financial institutions. • Contribute to process standardization and continuous improvement of administrative and legal workflows. • Work on systems integration and automation of routines to optimize operations. • Participate in technology implementation projects and process reengineering. • Assist with basic budget control and analysis of legal expenses. • Support management of legal vendors and communication with external law firms. • Map operational risks and propose corrective actions. • Conduct internal training on processes, systems and best practices.

• Responsible for daily operations of direct reports while driving operational initiatives • Leads clinical implementation efforts within an assigned team or partner for new technologies and workflows, which includes working in close partnership with operations leaders, product, engineering and design teams • Addresses clinical and administrative concerns such as troubleshooting and issue resolution, ensuring staff coverage and gathering feedback on care delivery systems to ensure safety, compliance, accuracy and standardization • Drives change management and adoption of new tools and workflows at team level by partnering with training and peer leaders. Serves as a subject matter expert between technical and frontline teams and incorporates post-implementation analysis, feedback • In partnership, helps design and evolve workflows by assessing current to future-state needs that maintain quality and safety standards • Works with teams to collect data, insights and front-line feedback to help inform decisions and standardize processes across assigned teams to support scalable work • Achieves and upholds Twin service care goals and standards, which includes monitoring and managing team performance, meeting SLAs and targets • Guides development, organization and communication of nursing/team policies and procedures • Supports recruitment, training and mentoring • Aligns and collaborates with cross-functional team leaders, and serves as team representative and/or subject matter expert on initiatives and projects • Promotes member self-care management by utilizing clinical judgment, critical thinking skills • Collaborates closely with team colleagues including nurses, health coaches, providers, and operations teams to drive a seamless experience for members • Provides timely responses and feedback to colleagues regarding member care, escalations and issue resolution • Organizes accurate records and maintains confidentiality according to federal law and Twin • Generates and analyzes reports as needed for management, identifying trends, any concerns • Participates in on-going education and performance improvement activities • Additional duties as assigned • Other duties as assigned