Our client, a medical device company in Galway are currently looking to recruit a Quality System Project Manager for their site.
This position is responsible for planning, directing and coordinating computerized systems projects within the Quality & Regulatory function. It includes the successful delivery of projects for the quality and regulatory function, focused on business planning and deployment activities.
This job function has accountability for complying with the applicable elements of the Division Quality System and the associated procedures.
The Project Manager will champion the Quality & Regulatory function, ensure that the business requests are met, and the Quality & Regulatory Processes are followed. The position shall promote adherence to the project management methodology (MAPS). This role will interact with the Quality & Regulatory Division & Business Unit leaders, shared services leads and IT leaders. The candidate will be involved throughout the project lifecycle and will be accountable for the business delivery of the project, representing the Quality & Regulatory function, ensuring an achievable and successful outcome.
The position holder will be accountable for articulating and promoting the benefits of their project to the Business Units and sites. He/She will work closely with the entities to ensure a well communicated project of change activities with appropriate delivery dates aligned to key business activities and priorities. He/She will liaise with both the Division and Business Unit teams to ensure consistent delivery of Quality & Regulatory projects. He/She will also be a key point of escalation for the business on the projects. The role shall be office based with travel expected, when necessary.
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 13485, FDA 21CFR820, 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.
- Lead and manage Quality and Regulatory projects in partnership with Division Quality and IT leadership expectations and priorities.
- Work directly with the Program leaders to identify, plan and implement the project scope, ensuring the business project risks, issues, and dependencies are understood, communicated and baselined, and ensuring any assumptions are verified.
- Represent the Quality & Regulatory program and take an active part in steering groups to ensure that project oversight and governance is in place and effective.
- Interact with all Division functions (IT, Quality & Regulatory, HR, etc.), Business Unit entity leaders and stakeholders to provide effective alignment, collaboration and engagement, program management and project execution, to facilitate change within the Division.
- Work with Business Unit leaders to plan the budgets and forecasts on a rolling basis.
- Develop a close working relationship with the Business Unit and Division teams to understand the requirements, and to inform their decision making.
- Embed continuous improvement strategies into the project discipline whilst operating a controlled, structured and well managed projects.
- Accurately report and present the status of the project, citing escalation, risk and issues to the program management office.
- Fluent business English speaker
- Bachelor’s Degree or equivalent qualification (as a minimum)
- Experience (i.e. greater than 3 end-to-end projects) of successfully managing Quality, Regulatory projects, with demonstrable evidence of effective design, delivery and problem-solving skills
- Project team management experience leading a team greater than 3 FTEs, with a mix of internal and contractor team members, spread across multiple time zones
- IT projects experience as a business project manager
- PMP certification or equivalent
- Strong technology awareness in line with technologies in use across the Division (e.g. Oracle Agile PLM, DocXellent ensure, SalesForce.com and SharePoint)
- Supplier qualification and management experience
- 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
- Experience of establishing and leading teams, and coaching and developing team members to maximize individual and team effectiveness
- Attention to details by documenting meetings, action items and objectives
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