Head of Quality – Compliance

This is a fully remote position, open to applicants in Nigeria, +1 more country.

📋 Description

• Take charge of the quality assurance strategy and its implementation across Axmed's marketplace operations.

• Develop and enhance the global Quality Assurance Programme and Quality Management System strategy.

• Ensure alignment of quality systems with GMP/GDP standards and WHO MQAS requirements across various jurisdictions.

• Oversee the digital-first Platform eQMS, which includes organization and product qualification, validation, and QA release.

• Utilize AI and data for dossier and CoA screening, anomaly detection, document review, and ongoing monitoring.

• Establish and lead the Quality function while cultivating a team proficient in AI.

• Manage and execute risk-based internal and external audit programs.

• Direct client and regulatory inspections as well as supplier GMP/GDP audits.

• Maintain the enterprise Risk Register and report on exposure and mitigation strategies to the COO and ELT.

• Oversee deviations, complaints, CAPA, and product recalls, including accountability for recalls when necessary.

• Ensure adherence to local regulatory requirements in each operational market.

• Design and implement the annual risk-based QC sampling program.

• Collaborate with Regulatory Affairs, Commercial, and Technology to ensure SOP adherence, conduct program reviews, and enhance quality features.

• Represent Quality in high-level commercial and regulatory decision-making.

• Advocate for company-wide quality and compliance training, coaching, and ongoing improvement initiatives.

⛳️ Requirements

• Extensive knowledge of GMP/GDP and quality systems in pharmaceutical or medical device procurement, particularly WHO MQAS.

• Proficient understanding of EMA, Swissmedic, and FDA regulatory requirements.

• Hands-on experience with prequalification, supplier qualification, and managing product recalls.

• Experience in owning and enhancing a comprehensive electronic Quality Management System (eQMS), including documentation, SOPs, and records management.

• Proven experience in conducting external GMP/GDP audits and internal audit programs.

• Successful history of hosting and successfully passing regulatory or client inspections.

• Familiarity with applying data and AI in quality processes; prior implementation of such tools is a plus.

• Ability to simplify regulatory requirements into practical, usable processes.

• Over 10 years of quality assurance experience within the pharma and/or med tech supply chain or manufacturing sectors, at a global or multi-country level.

• Demonstrated success in leading or building a quality function.

• Previous experience as Head or Director of Quality Assurance, or equivalent senior role, is preferred.

• Experience in managing or coordinating QC testing programs in pharma or med tech.

• Experience in emerging markets and multi-country supply chain and regulatory compliance.

• Background in managing teams and reporting to Executive Leadership Team or C-suite level.

• Familiarity with the health procurement or global health supply chain sector is highly desirable.

• Practical experience utilizing AI tools to enhance quality or compliance workflows.

• Bachelor's degree in Pharmacy, Pharm.D., or an equivalent recognized qualification.

• Must possess the legal right to work in the country of residence; no visa sponsorship or relocation assistance is available.

• Comfortable operating in a lean, remote-first startup environment with distributed teams across different 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 career advancement.

• Mission-driven role aimed at enhancing healthcare equity.