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 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
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 TPMs, 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
Requirements
Bachelors Degree in: Quality, Manufacturing, Life Science or Technical field is required
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 of CAPA systems is required and experience is desirable
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 multiple projects within defined timeframes
Knowledge of applicable regulatory standards and requirements for nutritional products for international markets.
