Sharon M Walsh Email & Phone Number

New Jersey, United States

➢ Partnered with client project manager on a tech transfer project for the manufacturing of high dose flu vaccine. Engaged to ensure critical tasks and change controls were addressed prior to FDA inspection. Planned and managed the start-up of manufacturing at the site. Coordinated cross-functional activities and provided regular status updates to senior leadership.➢ Developed a business plan for a newly integrated Quality organization after the acquisition of a smaller pharmaceutical company by a large, global pharmaceutical company. The plan included the strategy for change management and recommendations for process integration and optimization. ➢ Led project to improve responses to regulatory authorities (i.e., FDA, EMA, etc.) at a large, global pharmaceuticals company. Developed a business plan that defined strategies for organizational and operational changes for the Quality organization after the acquisition of another pharmaceutical company. ➢ Developed portfolio and program management processes for a gene therapy company in the pre-clinical and clinical phases of product development. Developed an integrated program plan for the 3 products in development; each in various stages of product development lifecycle. Provided status updates to the CEO via a dashboard.➢ Provided project management leadership for a start-up pharmaceutical company in the pre-IND stage of development. Engaged executive team in development of an integrated project plan and identified critical path tasks required for IND submission. ➢ Program manager at pharmaceutical company with several anti-body therapies in their pipeline. Planned pre-commercialization activities including the development and implementation of their commercial compliance program, field personnel training, and pre-launch activities. Engaged global stakeholders from Clinical, Medical Affairs, PV , QA, and Regulatory. Mitigated risks arising from drug approval delays and turnover of key personnel.

United States

Project Manager at a large, global pharmaceutical company. Led a business process improvement / process change initiative to align site processes with corporate goals / processes. Managed risks arising from the unplanned absence of the project sponsor and subsequently a key stakeholder.

Princeton, Nj

Managed the project delivery team, created marketing plans and materials, and oversaw development of intellectual property for data-related projects such as predictive analytics, data warehouses, data cleaning, aggregation, and migration to warehouse. Provided project planning best practices guidance to clients.

Yardley, Pa

Managed client accounts, relationships, and projects for several clients.➢ Program manager for a large, global pharmaceutical company. Partnered with global stakeholders from three disparate business units to define and deliver project goals, align requirements, and manage risks for concurrent projects. Facilitated global, cross-functional decision making, and drove progress to successfully deliver the multi-phased program. ➢ Corporate strategic planning and executive level KPI reporting project won by demonstrating the value to the customer’s new leadership team after the client's/private equity company's acquisition of several OEM/specialty parts companies.

Princeton, Nj

Led team comprised of 15 employees and 20 consultants. Managed several projects that delivered strategic value to the organization.

Greenwood Village, Co

➢ Selected by the CEO to establish the international projects organization and unify operations after multiple acquisitions in Europe and Australia. Provided executive support to global clients and projects. Directed the activities of teams across four continents. Managed a team of 25 full time employees and 200 contingent workers. ➢ $10 million in international business won in the first year by championing cooperation across geographies, educating stakeholders, identifying global leads, and ensuring frequent and open communication. ➢ Transformed the potential failure of a $53 million project and reestablished a positive client relationship. Joined 1.5 years into a 5 year project. Succeed by quickly identifying issues with the schedule and deliverables, developing an action plan, adding or replacing team members as needed, revising the project plan, and working to re-engage stakeholders, build confidence, and energize the team. ➢ Project Manager for two pharmaceutical packaging manufacturing subsidiaries. Led effort to define operational processes required to bring each site online. Worked with internal quality and compliance managers to establish compliance procedures. ➢ Project Manager for a mid-size pharmaceutical company. Managed a commercial compliance project after the establishment of the Sunshine Act. Project defined changes to operational processes and procedures for capturing and reporting data required for compliance.

Led global project for the newly divested group of medical device manufacturers. Device companies had previously operated independently. Worked with global leaders to define and gain alignment on organizational changes, the integration of operational processes, and process improvement. Led rollout effort across all business units and geographies.