Fairfield Transformation- Sr. Project Leader Ingredients
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
PRIMARY FUNCTION / PRIMARY GOALS / OBJECTIVES:
- Ensure that the Ingredient Supplier Quality Assurance program meets the most current global regulatory requirements for pediatric and medical nutrition products.
- Assure a high-quality supply of incoming materials through evaluation and development of Abbott Nutrition ingredient suppliers.
- Work with ingredient suppliers as part of an ongoing supplier management lifecycle process to support the supplier qualification, performance monitoring and continuous improvement processes.
- Support plant quality assurance, operations and purchasing groups globally to ensure that proper incoming material documentation involving CAPA, testing/release, acceptance plans and specifications are compliant to Corporate, Division, and regulatory requirements.
- Participate in and provide input for the on-going review of key performance indicators or other sources of quality data to ensure that ingredient supplier performance is monitored and the corrective action is taken as required.
- Manage the Ingredient Supplier Quality Assurance Program for ANSC-Nutrition.
- Act as the Subject Matter Expert (SME) for the Ingredient Supplier Quality Assurance Program process. Take a leadership role in the management, monitoring and follow up of suppliers to assure that there are no negative or adverse impacts to finish product as a result of supplier controls.
- Support the selection and development of new ingredient suppliers and assure that product launches and Division initiatives are met. Maintain control of the approved supplier status of ingredient suppliers.
- Create and maintain Supplier Quality Agreements for all critical/high risk ingredient suppliers.
- Assure compliance to the Supplier CAPA system for incoming materials and monitor and react to recurring events on a monthly, quarterly and/or annual basis to reduce or eliminate nonconformities.
This includes monthly monitoring of complaints and leading investigations to identify root cause and corrective actions, and closing out tasks and corrective actions plans, as needed.
- Provide operational support to ANSC global operations by resolving incoming material issues and ingredient supplier-related issues.
Lead investigations and support resolution and approval of exception reports (both Plant and Division) that are compliant with Corporate and Division policies.
- Use a risk-based approach to manage the global ingredient supplier selection, qualification, monitoring, and classification process and assess supplier performance.
- Assure that proposed changes to the supplier processes or supply base are approved and compliant to Corporate and Division procedures.
ACCOUNTABILITY / SCOPE:
This position reports directly to the Ingredients Quality Manager of AN Design Assurance and is challenged to effectively execute and manage the overall ingredient supplier quality assurance program. The failure to provide sufficient oversight can result in regulatory vulnerability and regulatory action. In addition to the FDA or any other regulatory agency's impact, this position's actions when dealing with supplier-related issues can result in product recall or liability suits that may result in adverse publicity, branding and a reduction of sales on a long term basis.
The demanding regulatory environment requires that this position is accountable for sound technical judgment when dealing with suppliers on an on-going basis with minimal direction.
Experience in Quality Assurance: At least 5 years in a Quality Assurance, Supplier Management or a closely related position in a federally regulated industry.
Demonstrated leadership and technical skills in supplier management, supplier assurance or control.
Experience in performing/leading supplier on-site assessments and working independently when troubleshooting supplier issues.
Computer literate (i.e. Basic Microsoft Word applications).
Ability to provide technical expertise, consultation and recommendations to suppliers to improve product performance and quality assurance principles.
Ability to successfully interact and communicate with all organizational levels internally and externally (e.g. suppliers, internal customers, or external regulatory bodies).
Demonstrated ability to manage several activities / projects at once, organize / prioritize work.
Rationale - Must have technical knowledge and experience in a regulated industry coupled with demonstrated skills the ability to communicate with suppliers and to provide technical expertise, consultation and recommendations between the supplier and ANSC to improve product performance and quality assurance principles.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
Yes, 20 % of the Time
Abbott Laboratories - 12 months ago