Quality & Regulatory Senior Project Manager

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I am currently working with a leading medical device company located in Galway who have a Quality and Regulatory Senior Project Manager role open at the moment. They create more possibilities for more people at all stages of life. Today, 99,000 people are working to help people live not just longer, but better, in the more than 150 countries we serve.The RoleThe Senior Program Manager will champion the Quality & Regulatory function, ensuring that the QA and RA initiatives are aligned to the Division strategy, with the programs prioritized, funded and initiated. This role will interact with the Business Unit leaders,shared services leads and Division functional leaders. The role will be accountable for the delivery of the successful transition from initiation/intake to execution of project, ensuring an achievable and successful outcome. ResponsibilitiesCarries out duties in compliance with established business policies and procedures.Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.Perform other duties and projects as assigned.Governance & Engagement: Sponsor's engagement, governance definition, intake of initiatives, Division and Business Unit strategy integration and alignment, Quality & Regulatory function strategic planning oversight, initiative prioritization (incl. business cases), dependency mapping and coordination.Communications: Stakeholder mapping, expectations capture, communication plans, lead communication and engagement forums, involvement and sponsorship to initiatives and portfolio reportingScope and Business Change Management: Intake coordination, initiatives pipeline management and tracking, value/synergy realization, high level requirements and scope capture, change, impact & decision coordination, facilitate investment decisions, RCEs & financial submissions, resource modelling/planning, transition planning and coordination from initiative to project/program execution and products modeling and analysis including productivity analysis. RequirementsFluent business English speaker with good interpersonal, excellent communication and presentation skillsMinimum Bachelor's Degree or equivalent qualification in a scientific discipline. Master's degree is preferred.PMP or equivalent certification in Project ManagementAt least 7-10 years experience in Project Management/Program Management in Regulatory or Pharma projects, with demonstrable evidence of effective execution and sustained compliance to regulations and standardsExperience in handling and delivering multiple projects (more than 15) at the same time; with proven success in delivering a very high value.Driven projects in a complex and multi stakeholder environmentExperienced in working with cross-functional teams such as Quality, Regulatory, Supply chain, Finance, Marketing etc.Supplier qualification and management experience; with hands on experience in contractingExperience of working with global teams with effective project executionTeam leadership experience with direct reporting, mentoring and providing guidance to a junior resourceInternational exposure and experience, operating across multiple time zonesExperience of working with GMP compliant sites and achieved effective delivery with TPMs and in house manufacturing sitesIf you'd like to discuss the chance of becoming Quality and Regulatory Senior Project Manager , please send across your current CV and we can have a confidential conversation about this opportunity. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales