Job Details

Quality Assurance Manager – Disposition

Req ID: R0027233
Category: Quality
Location: Lexington, MA US
Posted Date: September 13, 2018

The role is accountable for disposition activities with the QA Disposition group supporting the Lexington Site within the Biologics Operating Unit

The scope of operations performed in support of manufacturing activities includes:

– cell bank

– unpurified bulk (UPB)

– drug substance (DS) disposition

– management of quality systems from initiation to closure (deviations, investigations, CAPAs, change controls, etc.)

This position will be responsible for:

– Timely disposition of UPB and DS in line with global regulatory expectations and Shire standards. 

– Working with cross functional groups in each department supporting manufacturing operations within the Lexington Site organization.

– Ensuring consistency and communication, where appropriate, across the manufacturing operating sites. 

This individual will partner closely with the following groups to ensure timely disposition of intermediates and products:

– Quality Assurance groups

– Quality Control

– Manufacturing

– Compliance

– Materials Management

– Regulatory

– Supply Chain

Experience:

– Minimum of 5 years experience

– Ideally within Pharma or Medical Device

– Strong collaboration skills

– Ability to communicate effectively, both written and verbal, with leadership

– Strong Project Management skills

– Ability to effectively work with cross functional groups

– Degree Required