Oversee the implementation of a new Company Quality Systems, inclusive of ownership and coordination of Corporate QA records (CAPAs, Deviations, and Change Controls), authorship of corporate guidance and procedures; development and oversight of corporate governance processes (Corporate Change Control Board meetings, Quality Review Board meetings, Corporate QA metrics).• Manage global QMS system heads for eLMS, DMS, Deviations, CAPA, and Change control.• Evaluate and implement a deviation, CAPA, and Change Control certification program, allowing standardization across the global network.• Drive a strong quality culture based on a risk-based approach across the network, working with site key stakeholders.• Own the global network Quality Management Review metric (QMR), Reporting the company’s quality management performance to the CEO.• Maintain and support site inspection readiness, working cross-functionally with site quality heads.• Provide Quality mentorship when required across the network.• Support improvement for client batch disposition timelines.• Support Regulatory audits, including response activities and setup of QIP (Quality Improvement Plans). • Establish a structure for monthly site network Tier meetings (Quality Council)• Provide guidance and Authorship for high-level procedures and Work instructions. • Lead Compliance projects or represent QA in projects requiring corporate QA input and support.• Oversee budgeting for global QMS.

• Oversee Company Quality Systems, inclusive of ownership and coordination of Corporate QA records (CAPAs, Change Controls), authorship of Corporate guidance and procedures; development and oversight of corporate governance processes (Corporate Change Control Board meetings, Quality Review Board meetings, Corporate QA metrics).• Coordinate and support inspection readiness program inclusive of preparation and performance of internal/corporate audits and follow up on outcomes and resulting corrective actions.• Develop and implement a risk-based approach across multi sites for triaging deviations and product complaints.• Setup and implement Deviation/CAPA certification program, allowing global standardization/Uniformity for site authoring and QA approval.• Lead Compliance Projects or represent QA in projects where Corporate QA / Compliance input and support is required, including associated QA deliverables.• Coordinate improvements to the compliance and efficiency of Corporate QA systems, processes, and procedures. Contribute significantly to long-term strategy development.• Oversee budgeting activities for the team.

Deviations, CAPAs and Change Controls

Deviation, CAPA, Change Control