Amy Love Email and Phone Number

Direct oversight of site quality operations; validation, quality control, quality assurance, compliance, training, and regulatory affairs• Head of site quality operations with 4 direct and 42 indirect headcount• Ensure compliance with regulatory authority requirements by review and assessment of regulations for gaps and risk mitigation; led 2016 FDA inspection with no 483 observations noted• Management of site budget to ensure costs are controlled and reductions are made as needed• Help build and develop new corporate policies and procedures to create harmonization between multiple sites• View and approve site elevated complaints and out of specification reports• Oversight of all site quality metrics ensuring ability to meet and or exceed goals; including Complaints, Corrective and Preventative Action (CAPA), Right First Time (RFT) and training metrics• Direct site activities to evaluate, analyze, and report on product development, and process quality performance• Provide strategic leadership to ensure key site and departmental business objectives are achieved to include: cGMP compliance, product quality, continuous improvement, performance excellence, safety, recruitment, retention, deployment, training, attainment of financial targets, and business growth