JOB DESCRIPTION:
Have you ever wanted to make a difference?
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
Abbott Ireland
In Ireland, Abbott employs over 5,000 people across nine sites. We are currently investing in a tenth site in Kilkenny and have six established manufacturing facilities already located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
Abbott Nutrition
We understand that proper nutrition is the foundation for living the best life possible. That’s why we develop science-based nutrition products for people of all ages. Our products help babies and children grow, keep bodies strong and active, and support the unique nutrition needs of people with chronic illnesses — to make every stage of life a healthy one. Abbott is a leader in providing enteral nutrition feeding devices, including enteral feeding pumps and pump sets. Enteral feeding (also known as tube feeding) is a means of providing nutrition to people who cannot obtain nutrition by swallowing. Enteral nutrition contains all the calories and vitamins a person needs.
Project Manager Third Party MFG (TPM) – Quality Assurance
Under the general guidance of the Regional Manager TPM Quality Assurance, this position is responsible for provision of QA and Technical Support to the Abbott Nutrition Third Party Manufacturing Portfolio for manufacture of paediatric and adult Nutritional products. The Manager is responsible for compliance with Corporate and Divisional QA policies, procedures, standards and specifications as well as country specific regulations depending on the TPM location and markets. The Manager will be required to make quality risk based decisions to ensure product release, regulatory inspections and risk resolution does not result in recall of product or liability suits that may result in adverse publicity and a reduction of sales on a long-term basis whilst ensuring minimal impact to Division inventories and the ability to service customer demands. This position may have budget responsibility.
Primary Function / Primary Goals / Objectives:
Provide QA and Technical Support to Abbott Nutrition Third Party Manufacturers (TPM), TPM Operations, Affiliates and other AN Stakeholders
Responsible for QA portfolio expansion activities related to one or more specific TPM accounts within the global TPM portfolio – this may include both Business as Usual and TPM Start-up activities
Ensure compliance to Corporate and Divisional QA requirements and identify and / or resolve Quality gaps and / or issues relating to product design, manufacturing quality programs and product start-ups at TPMs
Lead Root Cause Analysis (RCA) investigations of quality events
Ensure Ingredient / Packaging Supplier approval and compliance at the TPMs
Ensures compliance and continuous improvement of audit and metric performance
Provides support to global nutritional and NPI project teams
Responsible for overall quality and safety of Abbott Nutrition products manufactured at those facilities
Manage a team who are responsible for all quality aspects at the assigned TPM.
Major Responsibilities:
Manage assigned Goals and Objectives to include individual, department and TPM goal management
Manage and coordinate a team of people to effectively manage the largest TPM within the AN network
Recruits, coaches and develops organizational talent.
Establish and maintain a robust long term working relationships with the key stakeholders at each TPM, and ensure TPM project activities are carried out within the defined timeframes
Work with Project Management on Global Nutritional Project teams as assigned (e.g. New Product Introduction projects, Margin and Profitability Initiatives and Ingredient/Packaging projects, to resolve key Quality issues and support product launches in various global markets
Utilize understanding of QA systems and problem-solving tools to provide alternative solutions to quality issues
Support disposition of product batches, facilitate investigations, troubleshoot and resolve quality issues in close cooperation with the AN TPM Operations team and the TPMs
Develop, implement and improve quality systems at the new TPM’s, which ensure:
AN policy and regulatory compliance
Initiation and review of Quality Documentation
Quality and Safety of AN products
Satisfactory performance on Metrics requirements
Training as required for Abbott Quality systems
Background:
Excellent problem solving and decision-making skills are critical to this position. The successful candidate must be able to demonstrate their risk-based decision-making ability
Communication skills are essential for this role.
Ability to work in a fast paced agile environment, critical thinking will be key
The successful candidate will be required to demonstrate their ability to manage and deliver multiple projects within defined timeframes
Knowledge of applicable regulatory standards and requirements for nutritional products for international markets.
A minimum of 5 years’ experience within a manufacturing plant – a Quality or Operations based role is required.
Experience managing third party manufacturers is preferred
Thorough knowledge of CAPA systems is required and experience is desirable
Thorough knowledge of and experience in application of GMP requirements
Education:
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, 20 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
