Stephanie Shah

• Overall oversight of operations in 7 plasma centers including collections, marketing, HR activities, training, and opening of new locations.
• Manage and develop center leaders for career growth.
• Routinely collaborate with Associate Director of Quality to ensure centers meet operational, quality and safety KPI metrics and data integrity investigations. May include joint center visits. Conducts routine tier meetings with Associate Director of Quality.
• Ensure center processes conform to operations standards by collaborating and communicating with staff and provide assistance to resolve operational issues with corrective action measures.
• Lead and or participate in operational projects and implementation of process changes.

Overall oversight of Operations which includes Collections, Marketing, HR Activities, training, and opening new locations.

• Guidance to center leadership in managing all aspects of operations.
• Oversee up to 7 locations throughout the US
• Quality oversight of up to 7 locations including training and deviation management.
• Ensuring compliance with company policies and procedures as well as regulatory compliance with state, federal and GHA regulations.

• Manage quality assurance communications and coordinate efforts to ensure center processes are robust and conform to quality standards.
• Work directly with Regional Operations Directors and Associate Directors and center compliance staff to reinforce requirements as specified by raw materials, package specifications, regulatory agencies, and company policies as defined in the Standard Operating Procedures.
• Provide guidance and administration of compliance reinforcing high levels of quality, safety and training at centers.
• Review and approve deviations, corrective actions and follow up
• Responsible for quality compliance of each center in the region through meeting all company, regulatory, and customer requirements to ensure the purity and efficacy of the plasma and the safety of donors and employees.
• Utilize appropriate remote tools to review and assess quality at centers. Visits centers to ensure overall center compliance.
• Participate in selecting superior center-based quality staff and ensure excellent training is provided.
• Act as liaison with External Regulatory Agencies, Auditors and Corporate.