This is a multi-faceted position which coordinates with every department at most North American and Global facilities to cover highly technical/complicated challenges related to colorants. The majority of time is spent on Product Stewardship/Supply Chain responsibilities. Also, this employee acts as Lead to Product Stewards globally and works to mitigate risk. Proficient in all activities of Color and Regulatory Administrator to ensure support as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
Mitigate Risk. Understand current manufacturing infrastructure. Balance operations infrastructure capabilities with customer requests and requirements (GMPs and raw materials vs healthcare/FDA regulations). Hold, review, interpret, and document legal requirements for customers based on their specifications.
Global lead for Environmental and Sustainability Initiatives: Oversee data collection and reporting of key environmental and sustainability metrics. Provide counsel to leadership team in shaping global environmental strategy and setting objectives and guide locations and customer engagement on environmental/sustainability issues.
Manage Drug Master Files. Support implementation of new DMFs globally and required FDA/EU medical testing, as devices are launched.
Oversee plastic regulations. Issue regulatory position statements, understand regulations and how they apply to our products, and maintain relevant data from all suppliers. Complete customer questionnaires regarding regulatory compliance and establish and lead lab testing of raw materials and finished articles.
Raw material qualification, pre-production, including regulatory compliance of end-use application and educating suppliers on regulations.
Work with customers and suppliers, explaining and educating them regarding regulations. Obtain and provide them required regulatory information.
Ensure production ability within customer requirements before production begins. Provide guidance to legal and global procurement before material changes/Force Majeure. Continuously improve and manage Global Materials Database, Globally Approved Materials Documents and New Material Qualifications. Assist in leading Force Majeure and Alternate Material Qualifications.
Manage Color Laboratory and Product Steward Specialist