Program Lead, IVDR

Job title:

Program Lead, IVDR

Company:

Abbott

Job description

JOB DESCRIPTION:About AbbottAbbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals — that create more possibilities for more people at all stages of life.Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve.Description
The position of Program Lead is within our Infections Disease (ID) business unit located in Galway, Ireland. This role will lead end to end IVDR. Program Lead will report directly to Director, Program Management, IVDR in the PMO Office.Responsibilities and Duties

• Lead the transition from IVDD to IVDR as part of the EU regulation change.
• Liaising with cross functional team to drive program/project plans, including timelines, budgets, and resourcing requirements; continually tracks progress against those plans.
• Responsible for reporting on assigned activities, collecting and collating inputs from cross functional teams to support project reviews with relevant stakeholders.
• Identifies and escalates project risks and communicates on project status to Manager.
• Proactively leads program milestones and effectively communicates cadence to ensure timely dissemination of information to management, program/project teams and stakeholders through regular governance meetings.
• Key contributor in structuring the program, focusing on efficiency gains, whilst complying with governing regulations.
• Key contributor in the generation of progress reports for delivery to management and stakeholders.
• Self-driven individual and team contributor responsible for highlighting gaps and drives resolution with functional leaders.
• Assists coaching program team members to ensure a comprehensive, integrated program strategy is delivered and assists generating formal training materials and delivering education sessions for applicable functional areas and regions.
• Responsible for leading 80 products for Regulatory Submission, Implementation and Post Market Surveillance.
• Responsible for driving continuous improvement.
• Working globally across 6 manufacturing sires, across different language barriers.
• Ensures cross functional members work as a ‘team’, focused on business goals and offers solutions to program challenges.
• Assists Hiring, Onboarding with potential to manage Direct Head Count (FTEs/Contractors).

Requirements

• A bachelor’s degree which could include supply chain, engineering, science, IT or equivalent business disciplines.
• 8 or more years of experience in Project Management, Operations, Manufacturing, Supply Chain, Quality/Regulatory or related function, preferably in medical device, pharmaceutical or consumer products.

Preferred Qualifications

• One or more professional certifications or equivalent experience (e.g., PMP)

Competencies

• Exceptional project management skills, with proven ability to clearly define objectives and priorities, establish milestones, anticipate and mitigate risks, lead cross-functional teams to meet and exceed goals in a dynamic environment, while maintaining strong attention to detail and quick recall
• Experience managing with ambiguity; demonstrated ability to take ownership of problems, exercise sound judgment and independently determine appropriate course of action where precedent may not exist
• Strong communication skills – in English in written and verbal; briefing, presentation, education/training skills
• Able to influence without authority
• Ability to work in a highly matrixed and geographically diverse business environment
• Ability to create & manage a vision, think strategically, plan and organize, innovate, analyse complex data and situations, and exercise sound judgment

The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Project ManagementDIVISION: ID Infectious DiseaseLOCATION: Ireland
Galway : Parkmore East Business ParkADDITIONAL LOCATIONS:WORK SHIFT: Ie – 37.5Hst0 (Ireland)TRAVEL: Not specifiedMEDICAL SURVEILLANCE: NoSIGNIFICANT WORK ACTIVITIES: Not Applicable

Expected salary

Location

Galway

Job date

Mon, 16 Dec 2024 01:10:24 GMT

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