Job Description

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 CO’s 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 (CO’s) 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 SOP’s 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.

Job Tags

Similar Jobs