Quality Project Manager - Third Party Manufacturing

Quality Project Manager - Third Party Manufacturing

Abbott Laboratories | Overland Park, KS, 66204, US
Salary Range:$117,000 – $153,000 Salary range estimated by Zippia

Posted 15 days ago

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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 109,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

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 pediatric and adult Nutritional products. The Project 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 Project Manager will be required to make quality risk based decisions to ensure product quality, 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.

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
* Complete CAPA activities for the assigned TPMs for event management, New product introduction and routine surveillance of products
* Lead Root Cause Analysis (RCA) investigations of quality events and complaint investigations
* 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

Major Responsibilities:

* Manage assigned Goals and Objectives to include individual, department and TPM goal management
* Establish and maintain a robust long term working relationships with the key stakeholders at each TPM and internal stakeholders, and ensure TPM project activities are carried out within the defined timeframes
* Manage complaint investigation, trending, documentation with the TPM and work towards overall reduction of complaints through proactive continuous improvement
* 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

Education:

Bachelor's Degree in: Quality, Manufacturing, Engineering, Life Science or Technical field is required

Background:

* A minimum of 5 years' experience within a manufacturing plant - a Quality or Operations based role is required.
* Experience managing third party manufacturers is required
* Thorough knowledge and experience of CAPA systems is required
* Thorough knowledge of and experience in application of GMP requirements
* 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.
* The successful candidate will be required to demonstrate their ability to manage and deliver a variety of projects and events within defined timeframes
* Knowledge of applicable regulatory standards and requirements for nutritional products for international markets is preferred

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