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Job Summary

The Global Finished Goods (FG) Packaging Development Manager will develop new global content and packaging/labeling materials in support of new product launches and base business projects as well as accountability for ensuring that all work associated with updates or changes to global labeling standards/procedures, training plans and process improvements, routing and approval of assigned labeling deliverables through Change Control Record (CCR) processes is carried out in compliance with relevant standards and regulations.

The Global FG Packaging Development Manager will be responsible for overseeing a cross functional collaboration with appropriate teams to ensure packaging and labeling continuity and compliance to country requirements. This position will also perform any finished goods packaging related deviations and investigations.

This position may also be responsible for the support for all departments at Prolacta Bioscience within the regulated environment as applicable to state, federal regulation, and international standards (i.e. FDA, EU, PMDA, MOH) for finished goods packaging.

·       5 years of related experience, preferably in the biologics or infant formula industry with a minimum of 3 years of finished goods packaging development experience.

·       Knowledgeable with FDA regulations and cGMP. Knowledge of FDA 21 CFR 106, 107, 110 and 117 is highly desired.

·       Any international regulatory packaging and labeling requirements knowledge preferred

  Moderate understanding of domestic and global development and implementation of labeling

·       Moderate understanding of medical and/or pharmaceutical regulations and standards

·       Moderate knowledge of medical device documentation development activities

·       Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness

·       Ability to evaluate change package and make decisions on resource consumption

·       Ability to work without supervision

·       Effective relationship building skills

·       Ability to produce and present clear, concise and professionally written communications and presentations

·       Positive attitude and motivation

·       Ability to operate in a complex matrix environment

·       Visionary and forward-thinking

·       High level of business acumen

·       Project management

·       Strong PC skills, Adobe, MS Outlook, Word, etc.

·       Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously

·       Strong attention to detail

·       Strong Critical thinking and decision making skills

·       Strong business ethics

·       Good working knowledge of FDA regulations relating to Food, Infant Formula, Pharmaceuticals or Biological Products.

·       Ability to interpret International standards for new market entry label and packaging requirements

·       ISO Implementation and or Certification experience is a plus.

·       Lean (Six Sigma) certification is a plus.

·       Direct experience with regulatory inspections required.