Manager, Quality Control

Job Description
What’s In It for You:
If you have been working in the lab environment for the past few years and want to grow in the latest trend of working in the virtual organization while still delving into the science of drug development, this is the role you are looking for.
The Role:
The Manager, Quality Control has responsibility for actively overseeing cGMP quality control activities associated with development and commercialization of the company’s small-molecule assets. This function operates within a virtual (100% outsourced) business model and the incumbent will be responsible for oversight of Quality Control activities of drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components. This person will also review and approve protocols, methods, reports, batch records and related GMP source documents, as well as have oversight of stability operations and reference standard programs, and transfer/site implementation of analytical methods to support future supply chain expansion. This person additionally will have responsibilities to actively manage data and document by using various software like Excel, istability, JMP, and Veeva for clinical and commercial projects. The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
This position is anon-site position at our Waltham, MA office with up to 10-20% domestic and international travel required, and will report to theAssociate Director, Analytical Operations and Quality Control.
What You’ll Do:
Review/approve controlled GMP analytical documents, e.G., analytical methods and associated validation protocols, reports, specifications, change controls, investigations, etc.
Compile data and conduct tracking/trending/statistical analysis of batch release data and stability data.
Support Root Cause Analysis and product impact assessment for investigations because of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
Manage the continued expansion of existing and the implementation of new departmental document and data management systems.
Manage the life-cycle performance of analytical methods from development through commercialization.
Perform QC review/approval of analytical test data for IPC testing, drug substance/product batch release and stability test data.
Author and/or review standard operating procedures (SOPs) relating to quality control.
Manage stability activities at CDMOs and compile/analyze stability data/reports using istability and JMP and maintain a reference standard and critical reagent programs
Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment