Program Manager

• Lead cross-functional teams to meet program objectives including scope, budget, and schedule.
• Prepare and/or support detailed Quality Improvement Plans and other business plans.
• Establish and prioritize project deliverables.
• Author and review quality system procedures and work instructions.
• Lead cross-functional teams to develop project timelines consistent with business strategy and expectations.
• Support audits and present completed and planned development process improvements, as appropriate.
• Identify and support implementation of harmonized software development tools.
• Drive program execution per milestone commitments (project timeline).
• Ensure appropriate impacts, risks, mitigations are developed and communicated in the face of requested or required program commitment changes.
• Prioritize program workstreams, consistent with business strategy.
• Facilitate strong collaboration among cross-functional core team members.
• Communicate with all levels of the organization the objectives, status, risks, and needs for the program.
• Identify potential roadblocks early and lead the team to develop and implement counter measures.
• Interface with appropriate internal and external resources (regulatory agencies, customers, etc.) to ensure development programs meet regulatory and customer requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications with all levels of employees, customers, contractors, and vendors.

Program Manager, Global Quality

Program Manager, Global Quality