QA Program Manager - IVDR

JOB DESCRIPTION:

12-month FTC

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, 114,000 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.

1.Position Summary

This position is responsible for planning, executing and coordinating projects within the Quality Systems function of Abbott Rapid Diagnostics (ARDx) Infectious Disease Business Unit. It includes the successful delivery of projects for the quality function, focused on global implementation activities.

This job function has accountability for complying with the applicable elements of the Business Unit Quality System and the associated procedures. The Quality Assurance Senior Project Manager will oversee critical global QA projects to enhance and standardize the quality system on a global scale.

This role will interact with the Business Unit leaders, Commercial QA and Manufacturing site QA leaders. The candidate will be involved throughout the project lifecycle and will be accountable for the delivery of the project, representing the business, ensuring an achievable and successful outcome. 

You will have accountability for articulating and promoting the benefits of the project to the Business Units and sites. You will work closely with the ARDx entities to ensure a well communicated project of change activities with appropriate delivery dates aligned to key business activities and priorities.  You will liaise with Business Unit/Site teams to ensure consistent delivery of Quality projects and will also be a key point of escalation for the business on the projects. 

2.Essential Duties and Responsibilities

• 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 behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Lead and manage Quality projects in partnership and alignment with BU and site Quality leadership expectations and priorities.
• Work directly with the global 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 program and take an active part in steering groups to ensure that project oversight and governance is in place and effective.
• Interact with functions and stakeholders (BU QS, Site Quality & Regulatory, IT, etc.) to provide effective alignment, collaboration and engagement, program management and project execution, to facilitate change within the Business Unit.
• 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 Site 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.
• Perform other duties and projects as assigned.

3.Education & Experience Required

• We are looking for candidates with a third-level qualification in a related field and 7-10 years of experience in a regulated manufacturing environment. This should include at least 2 years of project management experience within a Quality function. Experience leading complex global projects is a distinct advantage.
• Bachelor’s Degree in Life Science, Engineering or equivalent.
• Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ISO13485 / ISO14971 / 21CFR820 QSR, / MDR/ IVDR etc.)
• PMP certification or equivalent is desirable.
• Excellent interpersonal skills, capable of working independently and as part of a team with minimal supervision.
• Excellent computer skills, including proficiency in MS Office applications (Word, Excel, PowerPoint). Experience with Power BI is an advantage.
• Strong verbal and written communication skills, with the ability to convey information clearly and effectively.
• Proactive attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
• Ability to travel (~15% travel).

The base pay for this position is

N/A

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

JOB FAMILY:Operations Quality

DIVISION:ID Infectious Disease

LOCATION:Ireland > Galway : Parkmore East Business Park

ADDITIONAL LOCATIONS:

WORK SHIFT:Ie - 37.5Hst0 (Ireland)

TRAVEL:Yes, 15 % of the Time

MEDICAL SURVEILLANCE:No

SIGNIFICANT WORK ACTIVITIES:Not Applicable