Head of Quality – Compliance
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Head of Quality & Compliance governing quality systems, audits, recalls, and regulatory compliance. Axmed’s healthcare marketplace improves medicine access across low- and middle-income countries.
Responsibilities:
- Own quality assurance strategy and execution across Axmed's marketplace operations
- Define and evolve the global Quality Assurance Programme and Quality Management System strategy
- Align quality systems with GMP/GDP standards and WHO MQAS requirements across jurisdictions
- Lead the digital-first Platform eQMS, including organisation and product qualification, validation, and QA release
- Apply AI and data to dossier and CoA screening, anomaly detection, document review, and continuous monitoring
- Build and manage the Quality function and develop an AI-literate team
- Own and run risk-based internal and external audit programmes
- Lead client and regulator inspections and supplier GMP/GDP audits
- Maintain the enterprise Risk Register and report exposure and mitigation to the COO and ELT
- Govern deviations, complaints, CAPA, and product recalls, including recall accountability where required
- Ensure compliance with local regulatory requirements in each market of operation
- Design and run the annual risk-based QC sampling programme
- Partner with Regulatory Affairs, Commercial, and Technology on SOP adherence, programme reviews, and quality features
- Represent Quality in executive commercial and regulatory decisions
- Champion company-wide quality and compliance training, coaching, and continuous improvement
Requirements:
- Strong working knowledge of GMP/GDP and pharmaceutical or medical device procurement quality systems, particularly WHO MQAS
- Working command of EMA, Swissmedic, and FDA regulatory expectations
- Direct experience of prequalification, supplier qualification, and product recall management
- Experience owning and evolving a full electronic Quality Management System (eQMS), including documentation, SOPs, and records
- Experience running external GMP/GDP audits and internal audit programmes
- Track record of hosting and passing regulatory or client inspections
- Experience applying data and AI to quality work; prior deployment of such tooling is an advantage
- Ability to translate regulation into simple, usable processes
- 10+ years of quality assurance experience in pharma and/or med tech supply chain or manufacturing, at global or multi-country level
- Proven track record leading or building a quality function
- Prior Head or Director of Quality Assurance experience, or equivalent seniority, preferred
- Experience running or coordinating QC testing programmes in pharma or med tech
- Experience in emerging markets and multi-country supply chain and regulatory compliance
- Experience managing people and reporting to Executive Leadership Team or C-suite level
- Familiarity with health procurement or global health supply chain sector is a strong plus
- Practical experience using AI tools to improve quality or compliance workflows
- Bachelor's degree in Pharmacy, Pharm.D., or equivalent recognised qualification
- Must already have the legal right to work in the country where based; no visa sponsorship or relocation support available
- Comfortable working in a lean, remote-first startup environment with distributed teams across time zones
Benefits:
- Unlimited PTO
- Monthly wellness allowance
- Paid parental leave
- Flexible working hours
- Annual off-site retreats
- Fully remote work
- Competitive salaries
- Opportunities for professional development and advancement
- Mission-driven opportunity to improve healthcare equity
Similar Jobs
Cyber Security Engineer – Governance, Risk & Compliance
Cybersecurity engineer creating governance, risk, and compliance labs for Immersive One. Researching standards and simulating regulated-sector incidents to train users.
Portfolio Manager, GRC Risk Operations
Portfolio Manager leading third-party risk assessments, analysts, metrics, projects, and AI-supported workflows. Supporting Live Nation’s global live entertainment and ticketing operations.
Security Compliance Operations Specialist
Security compliance specialist supporting identity access, audits, and internal controls. Helping Accenture Federal Services strengthen technology and security programs for US government missions.
Senior Associate, Education Research Consulting – Compliance, IRB
Senior Associate consulting for Huron’s higher-education clients on research administration, IRB compliance, and operational transformation. Leading project workstreams, client collaboration, and junior staff mentoring.
Compliance Support Officer, Casual
Compliance Support Officer supporting Jhpiego’s USG compliance program through risk tracking, document control, training, and reporting. Remote role based in Baltimore, Maryland.
Corporate Compliance Administrator
Corporate Compliance Administrator supporting AKI’s CMMI, ISO, SBA, and federal contracting compliance programs. Maintaining calendars, audit-ready documentation, and regulatory reporting across subsidiaries.
Senior Operations and Compliance Analyst
Analista sênior monitorando operações, alertas regulatórios e SLAs para a TAG, fintech brasileira de recebíveis. Organizando dados, comunicados e dossiês de conformidade.
Regulatory Technician
Regulatory Technician managing CTIS data, document uploads, and submission support. Supporting ICON’s global clinical research organisation in bringing medicines to patients faster.
Senior Compliance Monitoring Specialist, Neurology
Senior compliance specialist monitoring Johns Hopkins neurology clinical trials remotely. Ensuring GCP compliance, data integrity, regulatory accuracy, and site quality across multicenter studies.
Principal Regulatory Affairs Specialist – Regulatory Liaison
Principal Regulatory Affairs Specialist advising global regulatory submissions for Thermo Fisher Scientific. Liaising with project teams and health authorities across clinical-trial programs.
Specialist, Japan Compliance Promotion
Compliance Specialist at Santen, a global ophthalmology life sciences company. Supporting Japan pharmaceutical and medical-device promotion through monitoring, training, reviews, and guidance.
Senior Compliance Manager
Senior Compliance Manager scaling compliance programs for Splash Financial’s consumer lending marketplace and automated loan technology. Advising product teams and bank partners while automating workflows and managing regulatory issues.
Principal Security Compliance Specialist
Principal Security Compliance Specialist driving enterprise security compliance across Akamai’s global cloud and edge platform. Architecting controls, audits, and authorization frameworks for commercial, federal, and defense requirements.
Director, Regulatory Affairs – Advertising, Promotion and Labelling
Regulatory affairs director guiding FDA-compliant promotion, medical communications, and global labelling for Autolus cancer and autoimmune therapies. Leading cross-functional strategies, reviews, submissions, and governance.
Compliance Manager
Compliance Manager building scalable EU/EEA compliance frameworks for DayOne’s hyperscale data centers. Developing policies, risk controls, regulatory processes, training, and investigations across jurisdictions.
Specialist, Regulatory Affairs – Middle East & Africa
Regulatory Affairs Specialist supporting Abbott medical device registrations across the Middle East and Africa. Preparing submissions, maintaining regulatory compliance, and supporting market entry activities.
Regulatory and Site Start Up Specialist
Regulatory specialist supporting clinical trial submissions, essential documents, and site activation for Precision for Medicine, a life sciences CRO. Coordinating Australian clinical trial start-up activities and regulatory compliance.
Regulatory and Site Start Up Specialist
Regulatory specialist supporting clinical trial submissions and site activation for Precision for Medicine, a life sciences CRO. Managing essential documents, ethics approvals, contracts, and country-specific compliance.
Senior GRC Consultant – Contract
Senior GRC Consultant delivering ISO, SOC 2, and GDPR compliance programs for Sprinto’s autonomous trust platform. Building AI-assisted playbooks and owning client engagement quality, margins, and delivery.
Compliance Operations Expert
Compliance operations expert designing global fiat, crypto, and stablecoin payment compliance solutions for Bybit. Supporting licensing, regulatory strategy, and cross-border settlement across LATAM, EU, and MENA.