Position Summary

Global Packaging Operations performs identification, validation and qualification of processes and components and manages the production for Clinical and Commercial products. This is inclusive of primary packaging, secondary packaging, and medical devices. The Packaging Manager will manage production activities at packaging COs inclusive of technical batch record review, pack and label design, label translation coordination, packaging and labeling production timelines, change controls, and performing corresponding Oracle transactions. Focus will be primarily Clincal Packaging Operations. This position manages contract packaging vendors to ensure timelines are met and serves as the Global Packaging Operations representative on relevant project teams to provide strategic input into label and packaging development.

Responsibilities

Oversee packaging and labeling operations. Set prioritization and schedule jobs with Contract Organizations (COs) and internal Quality resources and represent Global Packaging Operations in CMC subteams

Coordinate with internal manufacturing teams as it relates to labeling and packaging activities

Manage budgeting, quoting, contracting, and invoice payments

Contribute to the design and approval of labels for secondary packaging to meet country-specific labeling requirements, including translation of required label text into the appropriate languages and developing and routing label specifications for approval

Provide technical and document management support and oversee validation work at CO's as related to packaging production and integration of new processes or equipment

Collaborate with Quality Assurance to resolve production related deviations, CAPAs, and perform root cause analysis Update and develop SOPs for both internal and external processes performing regular gap analysis and identifying process improvements

Route changes and documentation through change control system (e.g., batch records, label specifications, finished goods specifications, packaging components)

Oracle transactions related to packaging

Other duties as assigned

Requirements

Bachelor's degree, preferably with a degree in packaging, materials science, chemical, mechanical, or a related field.

3+ years in the pharmaceutical packaging environment Ability to manage several programs

Strong interpersonal skills and the ability to thrive as part of teams that span multiple time zones and regions

Exceptional verbal and written communication skills

Problem-solving, influence, and decision-making skills

Flexibility and the capacity to manage fast-paced change

Experience with key software tools: SharePoint, Smart Sheet, OneNote, TOPS, Word, Excel, PowerPoint, Project, Visio, Teams, Zoom

Experience with Change Control systems

Experience with Oracle and Quality Management Systems (Veeva) or similar systems

Understanding of cGMP's and pharmaceutical industry procedures and regulations.