Program Manager, IVDR

Posted 10 Days Ago
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3 Locations
Senior level
Healthtech
The Role
The Program Manager will lead the transition from IVDD to IVDR within Abbott's Infections Disease unit, managing cross-functional team programs, tracking progress, reporting on activities, and driving continuous improvement across multiple manufacturing sites. Responsibilities include facilitating governance meetings, coaching team members, and ensuring compliance with governing regulations.
Summary Generated by Built In

     

JOB DESCRIPTION:

About Abbott

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 135 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 113,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott Galway

Abbott in Galway serves as the international hub for Abbott's Rapid Diagnostics business, which delivers annually more than 2 billion tests. As the global leader in point-of-care diagnostics, Abbott offers the broadest portfolio of best-in-class rapid tests, services, and handheld devices across all healthcare settings: the lab, the clinic, remote healthcare outposts, retail outlets, the patient's bedside and at home. Our industry-leading near patient tests and services are unmatched across key health and therapeutic areas, including: infectious disease, cardiometabolic & informatics, toxicology and consumer diagnostics.

Description
The position of Program Manager is within our Infections Disease (ID) business unit located in Galway, Ireland. This role will lead end to end IVDR. Program Manager will report into the Senior Manager, 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 approx. 80 products for Regulatory Submission, Implementation and Post Market Surveillance.
•    Responsible for driving continuous improvement.
•    Working globally across 6 manufacturing sites (with possible focus on one-two sites), across different language barriers.
•    Ensures cross functional members work as a ‘team’, focused on business goals and offers solutions to program challenges.

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/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:Project Management

     

DIVISION:ID Infectious Disease

        

LOCATION:Ireland > Galway : Parkmore East Business Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:Ie - 37.5Hst0 (Ireland)

     

TRAVEL:Not specified

     

MEDICAL SURVEILLANCE:Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:Not Applicable

     

     

     

The Company
Abbot Park, IL
97,838 Employees
On-site Workplace

What We Do

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

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