The Senior IMS Associate ensures organizational compliance with the Integrated Management System (IMS), including the Quality Management System (QMS), in alignment with ISO and other applicable industry standards. This role oversees document control governance to maintain the integrity, accuracy, and compliance of controlled documents and records, while also serving as an internal IMS auditor to assess system effectiveness and drive corrective and preventive actions. Through continuous improvement initiatives, the position supports management system maturity and promotes best-in-class operational performance. Manage end-to-end document control processes, ensuring proper creation, review, approval, publication, distribution, retention, and validity control of internal and external documents within the document portal. Ensure external standards, regulatory requirements, and industry updates are translated into applicable internal policies, procedures, and controls. Collaborate with process and system owners to standardize procedures and specifications, ensuring timely documentation, version control, and compliance alignment. Administer and govern the document review and approval workflow, ensuring accuracy, completeness, and adherence to IMS requirements prior to publication. Plan, conduct, and lead Process, System, Layered Process, and Legal Compliance Audits using a risk-based and process approach methodology. Manage audit schedules, performance tracking, and auditor competency monitoring, including quarterly evaluations and recognition programs. Drive gap analysis, corrective and preventive actions (CAPA), and continuous improvement initiatives to strengthen management system effectiveness and maturity. Support ISO, R2, and other regulatory certification readiness activities, including preparation, execution, surveillance, and sustained compliance. Monitor and manage Layered Process Audit performance and QIP metric compliance requirements in coordination with operations and support teams. Conduct training and awareness programs on IMS/QMS procedures, document control requirements, and compliance standards, including onboarding initiatives. Lead or support cross-functional QMS/IMS projects using structured methodologies (e.g., DMAIC, DMADV, Project Management Life Cycle) to drive operational excellence and compliance sustainability.
