• Lead Quality Systems staff including recruitment, performance management, hiring along with staff training and development.• Provide oversight, own, and mature the Quality Management Review (QMR) process. Ensure compliance with regulatory requirements and internal policies.• Provide guidance to staff to ensure that the Quality Management Review process are executed in a comprehensive, compliant, and timely manner.• Identify critical metrics for Quality Systems and develop Metric Control Plan.• Work closely with Global Quality Systems Owners and represent site at network meetings (Change Controls, Deviation/CAPA). Share outstanding practices, identify and implement improvements.• Establish Change Control Review Board, mature the process and ensure change controls are assessed by required functions and executed per plan and timeline.• Report metrics, including analysis of trends and recommendations on corrective actions. Develop robust plan to address repeat non-conformances. Present and call out to management as needed.• Establish deviation review board and ensure all product-related Deviations and CAPAs are initiated, investigated and resolved in a timely fashion.• Develop appropriate training material to facilitate training on quality systems.• Quality System SME for regulatory inspections and internal audits. Provide QS support during inspections.• Review and approve quality system records as needed.

•Manage instructional design for Learning programs, projects and initiatives for Global Manufacturing & Supply. •Coordinate instructional design strategies, programs, projects and initiatives from inception to completion in order to meet Learning outcomes and objectives. •Manage a portfolio of Learning design projects and initiatives focused on the development of instructional strategies, course materials, assessment techniques, appropriate integration of instructional technologies and best practices•Drive content presentation and interactivity decisions and assess content design approaches based on project requirements and technical specifications •Work closely with project managers and SMEs to ensure content is delivered on time and within specified parameters •Act as a consultant for local learning initiatives, for example in sites, to provide guidance on best practices for content and design •Expose business to new Learning methodologies and concepts, and support the implementation of new Learning approaches and technologies.

Lead a team of compliance professionals that managed company compliance training program while supporting GCP, GLP and GMP departments to ensure training programs meet regulatory requirements. Established company trainings standards which included; development best practices, compliance metrics, and a standardized training structure. Provided training support, through development of compliance training programs.• Upgraded and manage company Learning Management System (LMS) including the standardization of position descriptions to learning plans for all GXP groups.• Established compliance improvement groups for all GXP areas on documentation, internal system reporting, and training compliance best practices to reduce inefficiencies and maximize performance cross-functionally.• Speaker at the Medical Device, Pharmaceutical Manufacturing, and Quality Assurance Forum annual conference in 2012 & 2113; provided expertise on implementing learning based compliance programs and maximizing performance in regulated environments.

Led a team of technical training professionals operating under GLP regulations including the functions of hiring, goal setting, coaching, and development. Strategically partnered with leaders to identify department needs and develop innovative solutions. Ensured solutions met quality standards by assisting in the evaluation and monitoring of programs, developing metrics, and reporting findings.

Managed regulatory training program that included GLP and GMP initiatives for multiple sites; responsible for developing, planning and conducting training for new employees. Assisted in hosting regulatory and third party inspections.

Monitored regulatory and industry trends to ensure company compliance. A collaborative leader in the QA group, facilitated changes to Standard Operating Procedures, policies, and other documents. Lead process improvement opportunities and harmonization efforts to promote best practices. Provided regulatory oversight ensuring compliance of study; protocols, data, and reports to applicable standard operating procedures and regulatory guidelines. Supported operations management by providing regulatory guidance on process improvement initiatives.