Quality System Manager (Compliance)

About the role

You will own quality and compliance across our connected monitoring systems: computer system validation, 21 CFR Part 11 and GxP controls, SOC 2 and ISMS readiness, and device certifications. You will work closely with engineering, QA, operations and customers, and support client inspections and audits.

What you'll do

• Develop and maintain the Validation Master Plan (VMP), User Requirement Specification (URS), Design, Functional and Test Specifications (DS, FS, TS), and Traceability Matrices
• Plan and execute IQ / OQ / PQ testing for software and connected IoT systems
• Perform risk-based validation aligned to the GAMP 5 methodology
• Collaborate with engineering to build validation evidence into DevOps pipelines
• Implement and monitor controls for 21 CFR Part 11, Annex 11 and GxP-compliant systems (electronic signatures, audit trails, access control, backup, change management)
• Conduct periodic data-integrity audits and support client inspections
• Provide compliance training to development, QA and operations teams
• Define and monitor security, availability and confidentiality controls for SOC 2 readiness
• Maintain ISMS documentation, perform risk assessments and coordinate internal audits
• Create and update Standard Operating Procedures (SOPs), Work Instructions (WIs) and CAPA logs
• Work with airlines to get Mindlabs devices approved for use on board
• Identify vendors for CE and FCC certification and get Mindlabs devices certified
• Handle customers' compliance-related queries and follow them through

What we're looking for

• At least 2 years of experience with 21 CFR Part 11, GxP and GAMP 5 frameworks
• At least 2 years of experience implementing computer system validation (CSV)
• Good understanding of SOC 2, ISO 27001 (ISMS), GDPR and data-integrity principles
• Exceptional documentation skills and attention to detail
• Strong cross-team communication, audit presentation and training delivery skills
• Graduate or postgraduate degree in any discipline

Why Mindlabs

• Ownership of real problems, from the first prototype to customers using it every day
• Work across hardware, firmware, cloud and customer teams under one roof in Hyderabad
• Learn from people who have shipped monitoring for pharma, healthcare and food companies
• Products that keep medicines, vaccines and food within safe temperatures

About Mindlabs

Mindlabs Cloud (Alomind Labs Private Limited) builds IoT temperature and humidity monitoring for pharma, healthcare, food and logistics. Our wireless data loggers, cloud dashboard and real-time alerts help more than 200 companies keep medicines, vaccines and food within safe limits, with 21 CFR Part 11 compliant records. Everything is designed and manufactured in Madhapur, Hyderabad.