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Project Leader Third Party Manufacturing - Quality

Roles & Responsibilities

  • Bachelor's degree in physical or life science, engineering, business, or a related field.
  • 3+ years of experience in supplier quality assurance programs or related experience in regulated industries (operations, purchasing, or quality assurance).
  • Technical understanding of diverse technologies, product quality systems and supplier programs, with ability to advise and improve supplier performance.
  • Thorough knowledge of manufacturing processes and quality assurance principles; ability to operate to internal and federal regulations; experience in global, multi-cultural organizations.

Requirements:

  • Perform qualification and change activities for various commodities within Global TPMs to ensure continued product quality.
  • Support compliance projects related to ingredient, packaging, and finished good suppliers; write/review specifications, engineering studies, validation packages, and change requests.
  • Monitor the CAPA system to identify trends and root causes; develop effective CAPA plans and track QA metrics (KPI and CAPA) with regular reporting to Division and Corporate levels.
  • Maintain QA documentation and assure compliance; support supplier readiness for new product launches and coordinate with internal stakeholders across regulatory, RD, procurement, and packaging engineering.

Job description

     

JOB DESCRIPTION:

About Abbott

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 114,000 colleagues serve people in more than 160 countries.

Abbott in Ireland

Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

Please note any offer of employment for this position isconditional upon the successful completionof a pre-employment medical examination, including drug and alcohol screening, conducted by a medical practitioner designated by the Company.

Abbott Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure® and Glucerna®. – to help get the nutrients they need to live their healthiest life.

Our location in Ireland > Sligo , currently has an opportunity for a Project Leader Third Party Manufacturing - Quality

The primary function of the TPM group is to ensure a high-quality supply of finished products through evaluation, monitoring and development of Abbott Nutrition TPM suppliers worldwide.  TPM QA is responsible for working and communicating with manufactures as part of an ongoing supplier management process.  TPM QA supports systems such as supplier qualification, supplier development, supplier monitoring, and supplier event management.  In addition, TPM QA partners with cross functional teams to commercialize new products at TPMs.  

The Project Leader (TPM QA) will support account managers for all things quality across multiple suppliers that manufacture finished products on behalf of Abbott nutrition.  Within this role you will serve as the representative of Abbott to the supplier for numerous technical departments while coordinating activity with the supplier on behalf of regulatory, R&D, procurement, package engineering, and many more internal stakeholders.  Conversely, the individual in this role must also be responsible for accurately serving as a representative of the supplier in numerous meetings and exchanges internally within Abbott. 

WHAT YOU’LL DO  

  • Perform qualification/change activities for various commodities associated with Global TPMs.
  • Support compliance projects related to ingredient, packaging, and finished good suppliers.
  • Write and/or review specifications, engineering studies, validation packages, change requests, etc. to ensure product quality is maintained, and use quality tools to improve and assure quality.
  • Support and ensure technical readiness by the supplier/manufacturer in advance of new product launches, trials, etc.
  • Support TPM QA team in monitoring the CAPA system to identify trends, identification of root cause, and effective CAPA plans.
  • Track and trend established QA metrics (KPI and CAPA). Communicate monthly and /or quarterly data, as required, to the Division and Corporate Levels.
  • Identify new and / or modify and enhance existing sources of quality data for Continuous Improvement.
  • Maintain relevant documentation (i.e. QA policies, procedures, specifications, and acceptance programs) and assure these documents are current and compliant to division and corporate level policies and procedures as well as external governing bodies.
  • Support strategic projects associated with department and organization initiatives and goals.


Required Qualifications

  • Bachelor's degree in physical or life science, engineering or business, or a related degree
  • 3+ years’ experience in supplier quality assurance programs or related experience in operations, purchasing or quality assurance in a regulated industry 
  • Technical understanding of different technologies, product quality systems and supplier programs, and be able to provide consultation and recommendations to help suppliers improve their performance 

Preferred:

  • Thorough knowledge of manufacturing processes (production, logistics, and engineering) and quality assurance principles
  • Experience within a Global, multi-cultural organization.  
  • Experience within a federally regulated industry, Food industry a plus
  • Thorough knowledge of manufacturing processes and quality assurance principles; with the ability to operate to internal and federal regulations. 
  • Results-driven with ability to successfully interact and communicate with all organizational levels internally and externally (e.g. suppliers or external regulatory bodies); Demonstrated ability to manage several activities / projects at once, organize / prioritize work

MISC:

  • This position reports to TPM Quality Management.  The position will not have budget responsibilities or direct reports.
  • This is an on-site role - not a remote role.
  • There is no relocation provided for this role.

Learn more about our health and wellness benefits, which provide the secuity to help you and your family live full lives:  Abbott in Ireland | Benefits

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

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:

ANSC Nutrition Supply Chain

        

LOCATION:

Ireland > Sligo : Carbury Point, Finisklin Industrial & Technology Park, Sligo

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - Ansl39S5 (Ireland)

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     

     

     

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