Quality Manager, Portfolio Expansion - Nutrition - Columbus

at  Abbott Laboratories

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.

• Collaborating with TPM operations and process engineering groups in performing site assessments of potential TPMs.
• Conducting food safety and quality system audits of potential TPMs.
• Tracking and closing of corrective actions from audits.
• Identifying, elevating, and resolving food safety, food quality, compliance, and project risks associated with the qualification of a new TPM.
• Participating in the overall commercial project for launch of products at new TPMs
• Managing the quality related project deliverables to meet the overall commercial project milestones and goals.
• Creating Standard Manufacturing Plans (SMPs) to provide documentation of specification and manufacturing details to the TPM.
• Coordinating with Global Supplier Quality to assure qualification of new ingredients and packaging.
• Negotiating initial Quality Agreements with new TPMs.
• Participating in product FMEAs by providing input on details of the TPMs quality system and processes.
• Aligning the TPM quality processes with AN quality expectations and quality systems.
• Releasing first commercial batches for distribution including assurance of proper investigation and corrective actions for any nonconformances or potential nonconformances.
• Transitioning new TPMs to the TPM QA group who supports business as usual activities.
• Utilizing understanding of QA systems and problem-solving tools to provide alternative solutions to quality issues