Quality Compliance Sr. Specialist

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

This role is responsible for overseeing analytical method development, validation, transfer, and stability studies in compliance with ICH, USP, GLP, and regulatory requirements. Ensures data integrity, 21 CFR Part 11 compliance, and robustness of analytical systems across QC laboratories. Provides technical leadership for investigations, regulatory submissions, and audit readiness while collaborating cross-functionally to support product development and commercialization. Additionally, drives continuous improvement in laboratory compliance, analytical performance, and team capability.

Key Responsibilities 

• Review & Approve systems needed for analytical method development, validation, verification, and method transfer activities for pharmaceutical products according to ICH, USP, and regulatory guidelines.
• Review & approve system needed for stability studies including protocol preparation, sample scheduling, trend analysis, and reporting for accelerated and long-term studies.
• Review analytical protocols, reports, specifications, test methods and technical documentation to ensure GLP compliance and data integrity.
• Establish Systems to comply with 21 CFR part 11 in QC electronic data
• Oversight method transfers activities between R&D and QC laboratories ensuring reproducibility and analytical robustness.
• Oversight laboratory activities, troubleshooting of chromatographic systems (HPLC/GC), and optimization of analytical performance.
• Oversight laboratory Analytical investigations, OOS, OOT , trending activities
• Provide technical guidance, training, and performance monitoring for analytical team members from GLP compliance point of view.
• Oversight regulatory submissions, change controls, investigations, and audit readiness activities for QC labs.
• Oversight analytical sections of CTD dossiers (Module 3 – P Part) including Justification of specifications, impurity profiling characteristics, and supporting analytical documentation in compliance with ICH and regulatory requirements.
• Collaborate with cross-functional departments including RD, QC, QA, Regulatory Affairs, and Production to support product analytical development and commercialization.
• Oversight Raw material analytical methods Verification & validation.
• Oversight laboratories compliance systems to assure updated methods adaptions.

Qualifications & Experience 

• Bachelor's degree in Pharmaceutical Sciences or relevant field.
• Minimum 5 years of experience
• Strong knowledge of analytical methods (HPLC/GC), method lifecycle, and stability studies
• Expertise in ICH, USP, GLP, 21 CFR Part 11, and data integrity
• OOS/OOT handling, root cause analysis, CAPA, and audit readiness
• Troubleshooting, trend analysis, and data-driven decision making
• Experience with lab systems (LIMS/CDS) and continuous improvement

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!