Lead – Quality management - India - Sycamore Informatics Inc.

Description

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 management

Education

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

● 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 is mandatory.

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 Plans

Essential 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