Quality Project Lead

Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on making people see better to live better. The company has a 40-year track record of growth and diversification in Waterford – Ireland’s oldest city. 

From Waterford, Bausch + Lomb supplies eye health products to people across the world.

The company’s success in Waterford has been built on a great team who between them have thousands of years of experience of delivering the highest quality every time. As the facility has grown, new opportunities have been created for skilled people to join the team and take their careers to the next level in a global company with deep local roots in Waterford.

This is a two - year contract opportunity.

Duties

• Create a change management strategy for projects e.g. UKCA, Swiss AR, UDI, trial leaflets, IFU, product discontinuations etc.
• Maintain awareness of new requirements and compliance gaps,
• Create and manage associated projects activities and change records for evidence of traceability of the changes.
• Gather stakeholder requirements.
• Deliver timely informative communication to stakeholders.
• Manage cross functional input into the changes
• Manage multiple sequential and parallel schedules for delivery of changes to a set timelines.
• Liaise with cross functional teams on the strategy – local and international.
• Collaborate with global regulatory affairs to assess regulatory impact and deliver required regional approvals for the required changes.
• Create and manage detailed interactions of the changes to deliver implementation in line with the programme commitments
• Communication – manage team and stakeholder updates for requested changes.
• Other duties as assigned by Global Quality Director - Programmes

Requirements

• Third level Qualification in Science or Engineering
• Medical Device Standards and Regulations knowledge an advantage
• Project Management education and experience
• Cross functional project team member/leader
• Working Knowledge of MS project
• Working knowledge of change management systems/processes.
• Good communication skills (verbal & written)
• Decisive, self-motivated/capable of working on own initiative, and able to prioritise and a proactive approach.
• High attention to detail
• Medical Device experience
• CGMP

Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.

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