Address
Form of workThe Manager, QC (Quality Control) Technical Support and Compliance, provides technical leadership and guidance to the QC team by ensuring that continuous improvement projects are identified and implemented and that new changes/projects are assessed taking into consideration operating model and impact to cGMPs, SOPs and applicable guidelines and normative.
Leads Quality Control Technical Support team to support QC and AS&T, and interface with support groups to implement changes and continuous improvement processes.
Act as Subject Matter Expert (SME) for the product and process results, be highly knowledgeable of trends by providing input for analysis and driving innovations.
Authors QC investigations and meets all targets for timely closure and CAPA completion.
Works with the QC team to prioritize/coordinate of updates of SOP, WP, Form, etc. updates.
Support regulatory inspections.
Oversees and coordinates change control for method related changes.
Perform technical review and approval of QC assay results as needed.
Fosters and supports a team culture that is engaged and empowered.
Coordinate with Quality to ensure compliance and continuous improvement in the QC labs.
