Compliance Manager

About Mindlabs

Mindlabs is a technology company specializing in Supply Chain solutions with a focus on Track & Trace. Using cutting-edge temperature and humidity monitoring along with location tracking technologies, Mindlabs helps businesses minimize waste in food and pharmaceuticals. The company comprises passionate experts from IITs committed to enhancing supply chain efficiencies.

Key Responsibilities

• Create and update core validation documents including the Validation Master Plan (VMP), User Requirement Specification (URS), Design, Functional, and Test Specifications (DS, FS, TS), as well as Traceability Matrices.
• Organize and conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for software and connected IoT systems.
• Perform risk-based validation in accordance with GAMP 5 methodologies.
• Work closely with engineering teams to integrate validation evidence within DevOps pipelines.
• Develop and oversee controls compliant with 21 CFR Part 11, Annex 11, and GxP systems, covering electronic signatures, audit trails, access controls, backups, and change management.
• Conduct periodic audits to ensure data integrity and assist with client inspections.
• Deliver compliance-related training to teams across development, quality assurance, and operations.
• Define and track controls related to security, availability, and confidentiality to prepare for SOC 2 compliance.
• Manage Information Security Management System (ISMS) documentation, lead risk assessments, and coordinate internal audits.
• Draft and maintain Standard Operating Procedures (SOPs), Work Instructions (WIs), and Corrective and Preventive Action (CAPA) logs.
• Identify suitable candidates within various airlines to secure regulatory approvals for Mindlabs devices.
• Source and liaise with vendors for CE and FCC certification processes to certify Mindlabs devices.
• Engage with customers to address compliance inquiries and ensure execution of compliance activities.

Preferred Candidate Profile

• Minimum of 2 years' experience working with 21 CFR Part 11, GxP, and GAMP 5 frameworks.
• At least 2 years' hands-on experience in executing Computer System Validation (CSV) procedures.
• Strong familiarity with SOC 2, ISO 27001 (Information Security Management Systems), GDPR, and data integrity principles.
• Excellent documentation, detail orientation, cross-team communication, audit presentation, and training skills.