Packaging Operations Manager

RESPONSIBILITIES

* Initiate and manage label changes following regulatory guidance and Commercial style guides.
* Facilitate launches of products into new countries in conjunction with Commercial and Regulatory groups.
* Manage packaging and label changes in existing commercial products within Regulatory timelines.
* Communicate forecast, detail and communicate routine work items, coordinate internal resources to accomplish project goals.
* Facilitate issue resolution and problem solving with contract manufacturers
* Monitor production efforts at contract manufacturers.
* Lead weekly meetings with CMOs and capture discussions in minutes.
* Communicate with members of the manufacturing group and other departments to optimize the production schedule. Promptly elevate issues to upper management that compromise on-time drug availability
* Initiate Change Control, Deviations, and CAPAs through the Trackwise system.
* Other duties as assigned.

SCOPE

He/she will coordinate commercial material needs between the various manufacturing groups and the project teams to ensure that all product needs are defined and met.

EDUCATION

* Bachelors with minimum 5 years experience in the pharmaceutical field.
* Packaging and project management experience is desired

EXPERIENCE

* Minimum 4 years working with CMOs to plan and deliver packaged product per schedule.
* Working knowledge of current GMP/GCP regulations desired.
* Experience working with packaging artwork is a plus.
* Working knowledge of manufacturing processes
* Experience in supply chain - materials planning.
* Proficient in MS Office: Word, Excel, Outlook, PowerPoint, and MS Project
* Excellent organizational, interpersonal communication, and problem-solving skills
* Ability to find, communicate, and implement ways to continuously improve processes
* Proficiency with Oracle or other materials management systems knowledge desired
* Highly developed organizational and project management and influencing skills.
* Process development or technology transfer experience preferred.
* Excellent written and verbal communication skills.
* Negotiation skills.
* Networking skills
To find out more about Real please visit www.realstaffing.com