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Vacancy description

Quality Systems Manager in भारत

Jobgether

  • RemoteWork from anywhere
  • Full-timeStandard weekly hours

भारत

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Systems Manager based in India. This is a corporate-level quality leadership role focused on maintaining and continuously improving a standardized Quality Management System across multiple facilities. You’ll establish quality system requirements, strengthen governance, and help ensure consistent implementation across regulated operations. The role covers document and change control, training systems, CAPA, deviations, OOS investigations, complaints, audits, and quality metrics. You’ll use data and quality trends to identify systemic risks, drive corrective actions, and improve operational effectiveness. Working cross-functionally, you’ll partner with Quality, Operations, Product, Regulatory, Supply Chain, and facility teams. You’ll also serve as the primary administrator and business owner for an electronic QMS, supporting adoption, workflows, data integrity, and reporting. The position offers significant ownership and influence in a remote, high-trust environment focused on quality, compliance, and continuous improvement. Accountabilities: - Own, implement, maintain, and continuously improve the corporate Quality Management System, establishing standardized processes, procedures, governance, and quality expectations across facilities. - Provide guidance and support to facility Quality teams to ensure corporate requirements are consistently implemented while allowing for appropriate site-specific procedures. - Manage the corporate Document Control program, including document creation, review, approval, issuance, revision, periodic review, archival, obsolescence, and controlled distribution.

- Lead the Change Control program, ensuring changes are documented, risk-assessed, reviewed, approved, implemented, communicated, and verified for effectiveness. - Manage and support the Food Safety and Quality Training Program, including learning plans, training matrices, assignments, completion tracking, retraining requirements, and training records. - Serve as the business owner and primary Quality administrator for Veeva QualityOne, supporting configuration, workflows, user adoption, data integrity, reporting, and continuous improvement. - Develop, maintain, communicate, and support implementation of corporate Quality Standards, translating requirements into effective facility-level programs and procedures. - Provide governance and workflow support for CAPAs, deviations, non-conformances, and OOS events, including investigation quality, root cause analysis, action planning, approvals, effectiveness checks, trending, and timely closure. - Manage complaint trending and quality data analysis to identify recurring issues, emerging risks, systemic trends, and opportunities for corrective or preventive action. - Support Management Reviews by compiling, analyzing, and presenting QMS performance indicators, CAPA and deviation status, complaint trends, audit observations, training performance, and other relevant quality metrics. - Support internal, customer, regulatory, and certification audits by maintaining controlled, complete, current, and audit-ready QMS documentation and records. - Partner with Quality, Operations, Product, Regulatory, Supply Chain, and other stakeholders to integrate quality requirements into business processes, new initiatives, and organizational changes. - Monitor QMS effectiveness through metrics, trending, periodic reviews, and compliance assessments, recommending improvements based on risks, audit findings, recurring issues, and business needs. - Provide training, coaching, and technical guidance to facility Quality teams and other stakeholders on QMS processes, documentation, QualityOne workflows, and applicable standards.

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