Associate Director Qc Systems

1 month ago

Framingham, United States LFB Full time

SPECIFIC POSITION DUTIES (RESPONSIBILITIES, TASKS, ESSENTIAL FUNCTIONS)- Will focus on ensuring cGMP compliance within the overall QC group and creating, contributing, supporting, and overseeing the continuous improvement efforts tied to critical Quality Control processes, quality laboratory systems, and procedures.- Applies strong biopharmaceutical laboratory methodology scientific and technical expertise to organization, collaborates effectively engaging and partnering cross-functionally.- Evaluates QC documentation for compliance with cGMPs and possible ways to improve as appropriate.- Evaluates pathways to ensure science-based decisions are applied to effective closures of cGMP quality systems such as deviations, change controls, and CAPAs.- Evaluates QC systems and processes for compliance with cGMPs and possible ways to improve as appropriate.- Supports the QC group during inspections and audits coordinating with QA compliance counterpart to provide an independent cGMP voice.- Provides oversight to stability program, QC data trending, and method validation master plan.- Evaluates and sustains Data Integrity program.- Supports alert investigations of trends.- Supports the QC technology transfer workstream with method validation protocol reviews, execution oversight, reports, implementation of Part 11 compliant automated sample preparation solutions, comparability analysis report reviews for regulatory CMC submissions.- Evaluates QC equipment for overall compliance relative to maintenance and calibration, with a keen eye to cGMP compliance and areas for improvement.- Reviews the raw material control program (including material management, inventory, lot release and control) for its overall cGMP compliant state and possible areas for improvement as appropriate.- Supports ensuring USP and EP compendial suitability studies of raw materials and microbiological methods.- Provides expertise to source material test methodology in alignment with FDA-CVM regulatory expectations.- Supports laboratory investigations with outsourced laboratories.- Reviews the Assay Control, Reference Standard and OOS systems for a compliant state and areas for improvement as appropriate.- Inputs into the QC budget for defining additional systems, materials, or equipment that would improve the overall cGMP compliant state and/or process improvements.- Inputs to long-term planning of QC lab capabilities and capacity focusing on compliance and would be integrally involved in any implementation of new technologies/process improvements.- Assess QC processes using process mapping, data analysis, and other tools to identify improvement opportunities, advance culture of shared visibility and ownership to deliver to KPIs.- Facilitates discussions with QC equipment and process owners to identify possible areas for process improvements or improved cGMP compliance.- This role will require effective change management to embed process improvement changes throughout the QC group as well as communicating and documenting this with the overall Quality and Regulatory Affairs organization (including QA and RA).

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