Our client, a medical device company in Galway is currently looking to recruit a Quality & Regulatory Senior Project Manager for their site.
This position is responsible for planning, directing and coordinating a portfolio of projects/programs within the Quality & Regulatory function. This includes the intake of initiatives through to project start up for the quality and regulatory function. It is chiefly focused on governance, business and stakeholder engagement, scope, pipeline and business change management, strategic planning, communications and portfolio management.
The 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, the company’s 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.
The role will be accountable for articulating and promoting the benefits of programs to the Business Units and sites. You will work closely with the entities within the Business Unit to ensure a well communicated project of change activities with strong alignment to business unit priorities. You will also be a key point of contact for new initiatives or changes to ongoing initiatives. The role shall be office based with travel expected, when necessary. There will be project coordination and execution whilest transitioning approved projects/programs to execution and delivery.
This job function has accountability for complying with the applicable elements of the Division Quality System procedures, and the Division project management methodology.
Responsibilities and Duties
- Carries 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 behaviour 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 reporting
- Scope 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 modelling and analysis including productivity analysis.
- Fluent business English speaker with good interpersonal, excellent communication and presentation skills
- Minimum Bachelor’s Degree or equivalent qualification in a scientific discipline. Master’s degree is preferred.
- PMP or equivalent certification in Project Management
- At 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 standards
- Experience 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 environment
- Experienced 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 contracting
- Experience of working with global teams with effective project execution
- Team leadership experience with direct reporting, mentoring and providing guidance to a junior resource
- International exposure and experience, operating across multiple time zones
- Experience of working with GMP compliant sites and achieved effective delivery with TPMs and in house manufacturing sites
- Strong technology awareness in line with technologies in use across the Division (e.g. MS Projects, MS Office, MS Visio, SharePoint and Planisware)
- Experience of leading and implementing change initiatives and active stakeholder management
- Experience of working with culturally diverse groups of people, able to communicate effectively at all levels of the business, and with both technical and non-technical people, adapting approach to suit the audience
- Attention to details by documenting meetings, action items and objectives
- Additional languages (Continental European or East Asian desired but not essential)
For further information on this Quality & Regulatory Senior Project Manager role in Galway please contact Orla Crowley on 086 0449473 /email@example.com
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