Job Title: Quality and Compliance Consultant

Location: Remote position based in the United States or India

Travel: up to 25%

Reports To: CEO/Founder

About DeepHow

DeepHow is a Physical AI platform for industrial manufacturing, pharmaceuticals, and utilities that helps organizations capture expert know-how, turn it into dynamic work instructions, and drive verified execution on the front line.

The platform spans knowledge capture and sharing, AI-powered verification through Smart Compare and photo/video validation, and time and motion intelligence through guided workflows, SOP adherence, and real-time execution visibility. DeepHow supports customers from knowledge capture to verified execution, with strategic account expansion often cantered on verification, AI-guided workflows, and time and motion intelligence.

Role Overview The Quality and Compliance Consultant serves as an independent quality and regulatory subject matter expert with organization-wide responsibility for the Quality Management System (QMS), GxP compliance, Computer System Validation (CSV), SDLC oversight, AI governance, and data integrity. This role is responsible for leading core quality activities including vendor qualification, CAPA management, internal audits, management reviews, change management, procedure development and maintenance, training, and continuous improvement initiatives. The consultant also provides independent consultation and project leadership across the organization, supports risk-based and phase-appropriate GxP programs, and serves as a key advisor to clients and internal stakeholders on quality and regulatory matters.

To ensure objective oversight and avoid potential conflicts of interest, the consultant maintains an independent reporting relationship to executive leadership and operates separately from the functions subject to quality oversight. Product, Engineering, Operations, Customer Success, and other business units serve as collaborative business partners and peer stakeholders rather than part of the consultant's management chain. This structure enables the consultant to independently assess compliance, identify and escalate quality risks, facilitate investigations, support deviation and nonconformance management, recommend and monitor CAPAs, conduct audits, evaluate validation activities, and provide unbiased recommendations to executive management regarding compliance, quality, and regulatory obligations.

The role also requires direct engagement with employees at all levels to promote quality culture, regulatory awareness, and continuous improvement throughout the organization.

Key Responsibilities

- Serve as DeepHow's primary subject matter expert (SME) for Quality Assurance, Regulatory Compliance, and GxP requirements.
- Establish, implement, maintain, and continuously improve the company's Quality Management System (QMS).
- Lead and oversee QMS activities, including vendor qualification, CAPA management, internal audits,



management reviews, change management, and document control.
- Develop, review, update, and maintain quality policies, procedures, SOPs, and supporting quality documentation.
- Provide independent quality and compliance consultation, guidance, and project leadership across the organization and to DeepHow clients.
- Ensure compliance with applicable GxP regulations, industry standards, and regulatory requirements.
- Support and oversee compliance activities related to Software Development Lifecycle (SDLC), Computer System Validation (CSV), AI governance, and Data Integrity programs.
- Assess quality and compliance risks and recommend appropriate mitigation strategies and corrective actions.
- Lead, facilitate, and monitor investigations of deviations, nonconformances, quality events, and compliance issues.
- Provide guidance on the development, implementation, and effectiveness of Corrective and Preventive Actions (CAPAs).
- Conduct internal audits and compliance assessments to evaluate the effectiveness of quality systems and operational controls.
- Support the execution of risk-based and phase-appropriate quality and GxP compliance initiatives.
- Monitor regulatory, industry, and technological developments and assess their impact on company operations, products, and services.
- Develop and deliver quality, compliance, GxP, CSV, Data Integrity, and SOP training programs for employees and clients.
- Partner with Product, Engineering, Operations, Customer Success, and other business functions as an independent advisor on quality and compliance matters.
- Directly engage with employees at all organizational levels to promote quality culture, regulatory awareness, accountability, and continuous improvement.
- Support client-facing quality and compliance activities, including consultations, assessments, audits, and remediation efforts.
- Prepare quality metrics, compliance reports, and management review inputs for executive leadership.
- Escalate significant quality, compliance, validation, and regulatory risks to executive management, as appropriate.
- Champion continuous improvement initiatives that enhance quality, compliance, operational effectiveness, and organizational maturity.

Required Experience

- Strong knowledge of applicable FDA, ICH, EMA, MHRA, and other global GxP regulations, guidance documents, and industry best practices.
- Demonstrated expertise in 21 CFR Part 11, EU Annex 11, and Data Integrity principles.
- Experience establishing, implementing, maintaining, and improving Quality Management Systems (QMS).




- Extensive experience supporting and evaluating GxP computerized systems throughout their lifecycle.
- Proven ability to provide independent quality, compliance, and regulatory consultation based on practical industry experience.
- Knowledge of risk-based quality management principles and their application within regulated environments.
- Experience leading or supporting audits, CAPA programs, change management, vendor qualification, deviations, nonconformances, and management reviews.
- Experience supporting Software Development Lifecycle (SDLC) processes and Computer System Validation (CSV) activities.
- Knowledge of AI governance, software quality assurance, and data integrity controls within regulated environments preferred.
- Ability to earn and maintain client confidence through effective project planning, organization, execution, and communication.
- Solid interpersonal, consulting, facilitation, and stakeholder management skills, with the ability to influence all levels of an organization.
- Excellent written and verbal communication skills, including the ability to develop procedures, reports, training materials, and executive presentations.
- Ability to manage multiple projects and priorities simultaneously in a fast-paced and evolving environment.
- Minimum 10 years of experience in Quality Assurance, Regulatory Affairs, GxP Compliance, Validation, or related Life Sciences quality functions.
- Bachelor's degree in a scientific, engineering, quality, regulatory, or related discipline required.
- Experience developing and maintaining quality systems for SaaS, software, AI-enabled, or computerized systems.
- Experience with Computer Software Assurance (CSA) and risk-based validation methodologies.
- Experience conducting supplier and vendor assessments for software and cloud-based service providers.
- Experience supporting FDA inspections, client audits, or certification audits.
- Knowledge of applicable standards such as ISO 9001, ISO 13485, ISO 14971, GAMP 5, and ICH E6(R3) preferred.
- Experience working in life sciences, pharmaceutical, biotechnology, medical device, clinical research, or other regulated industries.

Travel Requirement

- This role supports global clients and cross-functional teams and therefore requires flexibility to accommodate meetings across multiple time zones when needed.
- Ability to travel domestically and internationally up to 10-25% for client engagements, audits, training, conferences, and company initiatives.
- Ability to travel to client sites and company locations to conduct audits, assessments, training, management reviews, compliance consultations, and quality system activities.
- Participate in industry events, conferences, and professional development activities to maintain awareness of evolving regulatory expectations and industry trends.
- Travel up to 25% domestically and internationally, as business needs dictate.

📌 Quality Assurance Compliance Specialist (India)
🏢 DeepHow
📍 India