Lead – Quality management

Designation -Lead – Quality management Experience -7+ years Location -Remote(India)Role Collaborate and perform activities related to Quality System development, training and process; lead internal audits; assist external audits/customer audits to assess compliance with expert guidance.Experience (in years) Minimum 7+ years’ experience in quality managementEducation Masters/Bachelor’s degree, preferably in Computer Science, Information science, Physics, Math or any other related discipline.Essential skills Quality & Compliance:QMS Implementation (ISO 9001), Internal/External Auditing, Regulatory Affairs Risk & Resilience:Risk Management (FMEA), Business Continuity Planning (BCP), Incident Management Problem Solving:Root Cause Analysis (RCA), CAPA Management, Process Improvement IT & Security:ISMS (ISO 27001), Computer System Validation (CSV/GAMP 5)Desired skills 1. Management Systems (QMS & ISMS) ● Maintain and optimize the organization's Quality Management System (QMS) in compliance with industry standards (e.g., ISO 9001, ISO 13485). ● Oversee the Information Security Management System (ISMS), ensuring data integrity and alignment with ISO 27001 standards. ● Ensure all Standard Operating Procedures (SOPs) and policies remain current, accessible, and strictly adhered to across departments. 2. Audits & Inspections ● Internal Audits: Develop and execute an annual internal audit schedule to identify gaps in process and security compliance. ● External Audits: Serve as the primary liaison for regulatory bodies, registrars, and client inspections. Host opening/closing meetings and manage audit logistics. ● Ensure all audit findings are documented and addressed within required timelines. 3. Problem Solving & Continuous Improvement (RCA/CAPA) ● Lead the deviation management process. Facilitate Root Cause Analysis (RCA) workshops using tools such as Fishbone/Ishikawa or 5-Whys to investigate non-conformances. ● Drive Corrective and Preventive Actions (CAPA) from initiation to closure, verifying the effectiveness of fixes to prevent recurrence. 4. Risk & Resilience (Risk Mgmt & BCP) ● Champion a risk-based approach to operations. Maintain the corporate Risk Management register, conducting regular assessments (FMEA) to identify operational and compliance threats. ● Own the Business Continuity Planning (BCP) framework. Schedule and lead disaster recovery simulations to ensure the organization can continue critical functions during disruptions. 5. Technical Validation (CSV) ● Oversee Computer System Validation (CSV) activities for enterprise software and automated equipment. ● Ensure all GxP-impacted systems are validated according to 21 CFR Part 11 and GAMP 5 guidelines (including drafting Validation Plans, IQ/OQ/PQ protocols, and Summary Reports).Certifications ISO:9001 Lead Auditor and/or ISO:27001 certification ismandatory .Summary The resource must have good verbal and written skills with the ability to analyze and prioritize tasks; must have documenting skills; must possess auditing skills and knowledge of ISO standards – QMS, ISMS etc.Roles & Responsibilities Contribute to activities related to: ● Customer Audit Program: Scheduling, hosting, and follow up on all customer audits. Follow up (to close out) on resulting corrective actions. ● Carrying out vendor audits, including on-site audit, providing vendors with formal reports which enumerate findings and observations requiring corrective action, and following up with vendors to assure that corrective actions are taken. ● Implementation and validation of internal computer systems (QMS, Training, CAPA) to support quality framework. ● Supporting clients undergoing regulatory inspections on which company systems have been used. ● Managing revision and approval of department Quality System Policy and SOPs. ● Performing internal quality audits of the organization, including quality system inspection and reporting for all product releases and release of projects. ● Maintain of cross-reference listing between the relevant sections and components of regulatory documents and how the products and services comply with those regulations cited. Maintain of cross-reference listing between the relevant sections and components of regulatory documents and how the products and services comply with those regulations cited.Additional responsibilities would include, but not be limited to: (Review products, systems, deliverables and documentation for:) ● Conformance to regulatory requirements and applicable guidance worldwide ● Escalation of issues pertaining to non-compliance, privacy, data integrity, and security for investigation and documentation of corrective and preventive action.Maintain documentation and report: ● Incidence of defects, audit findings and rates of occurrence and closure of outstanding issues. Review, process documentation for compliance with SOP’s and applicable regulations such as: ● Guidance and management of process and product improvement projects ● Review and resolution of QMS, ISMS, BCMS corrective actions and CAPA PlansEssential Experience ● Knowledge of the software development and testing process, especially for Agile development ● Experience in implementing ISO standards, conducting audits and working on CAPA ● Risk management, business continuity management experience ● Service management knowledge ● Ability to understand high-level technical concepts to provide review and commentary on project documents ● Excellent written communication skills in English ● Familiarity with regulated software requirements and standards ● Team player: Experience of working in teams and some exposure to cross-functional team interaction.Desired Experience ● Support experience with GxP products ● Understanding of clinical trial processes

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