Software Quality

Experience: 8+ Years

Job Location: Remote

Work Timings: 1:30 PM to 10:30 PM IST

Title: Software Quality & Compliance Manager

We are seeking an experienced Software Quality & Compliance Manager with 8+ years of expertise in regulated PMA environments. This role blends project leadership, regulatory oversight, and quality assurance, ensuring that all deliverables align with stringent compliance standards.

Key Responsibilities

FDA Compliance

• Experience in securing and maintaining FDA approvals for software products in regulated environments.
• Strong knowledge of the FDA approval lifecycle, including preparation, documentation, submission, and compliance monitoring.
• Proven ability to collaborate with FDA officials, address regulatory queries, and ensure timely approvals.
• Hands-on expertise in revalidation and recertification of already FDA-approved systems.
• Ability to establish robust processes that align with evolving FDA requirements and ensure ongoing compliance.

Regulatory Compliance

• Lead Computer System Validation (CSV) to confirm systems meet regulatory requirements, function as intended, and preserve data integrity.
• Ensure compliance with 21 CFR Part 11, Part 820, GAMP 5, and maintain alignment of the Quality Management System (QMS) with these standards.
• Review and verify Design History Files (DHF) and maintain complete documentation in the electronic Quality Management System (eQMS).
• Promote awareness of regulatory frameworks across teams.

Management Systems & Risk Oversight

• Drive adoption, integration, and continuous improvement of management systems (QMS, ISMS, AI Management System) across projects and support functions.
• Conduct risk management activities, including FMEA, information security, and AI-related risks.
• Facilitate awareness sessions on policies, processes, guidelines, and methodologies; support adoption of best-fit approaches (e.g., Agile).
• Oversee change control and ongoing compliance when systems are updated or modified.

Quality Assurance & SDLC Governance

• Provide oversight throughout the Software Development Life Cycle (SDLC), ensuring processes, risks, and quality standards are consistently applied.
• Review test strategies, risk-based test plans, traceability to requirements, and adequacy of functional, integration, system, regression, exploratory, and UAT testing.
• Assess the effectiveness of test automation, CI/CD quality gates, and supporting environments.
• Perform thorough reviews of release readiness and provide Go/No-Go recommendations.
• Facilitate root cause analysis and structured decision-making for process/tool/vendor evaluations.

Audit & Documentation

• Maintain accurate records and compliance evidence for internal/external audits, inspections, and certifications (ISO 27001, ISO 9001, HIPAA).
• Support teams in prioritizing and addressing non-conformances identified during audits.
• Provide periodic compliance and adoption summaries to senior management.

Required Skills & Qualifications

• 8+ years of experience in Software Quality Assurance, Compliance, or related roles within regulated industries (pharmaceuticals, healthcare, medical devices).
• Strong knowledge of 21 CFR Part 11, Part 820, GAMP 5, and experience in DHF reviews.
• Proven track record in management systems adoption (QMS, ISMS, AI MS) and risk management practices.
• Expertise in SDLC methodologies, test strategy evaluation, and validation oversight.
• Familiarity with eQMS platforms, test documentation practices, and traceability tools.
• Strong communication and leadership skills for cross-functional and global collaboration.
• Experience supporting ISO 27001, ISO 9001 certifications; working knowledge of HIPAA.