Senior Pharmaceutical Quality Specialist

Job Title: Senior Pharmaceutical Quality Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Work Arrangement: 100% Remote — Work From Home

Level: Senior

About the Role

We are seeking an experienced and detail-oriented Senior Pharmaceutical Quality Specialist to support pharmaceutical quality assurance, quality management systems, regulatory compliance, and continuous improvement initiatives. The successful candidate will help ensure that pharmaceutical products, manufacturing processes, documentation, and quality operations comply with applicable regulatory requirements, Good Manufacturing Practice (GMP) standards, and established quality procedures.

The ideal candidate will possess strong knowledge of pharmaceutical quality systems, deviation management, CAPA, change control, audit readiness, and quality risk management. This role requires analytical thinking, technical expertise, meticulous documentation, and the ability to coordinate effectively with Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Supply Chain, and external stakeholders while working in a fully remote environment.

Key Responsibilities

• Quality Management Systems: Maintain and improve pharmaceutical quality management systems (QMS) to support compliance with applicable regulations, industry standards, and organizational policies.
• GMP Compliance: Support adherence to applicable Good Manufacturing Practice requirements and relevant pharmaceutical quality standards, including applicable UAE regulatory expectations.
• Quality Documentation: Review and maintain standard operating procedures (SOPs), work instructions, quality manuals, specifications, validation documents, and other controlled records.
• Deviation Management: Review, investigate, and document deviations, nonconformances, out-of-specification events, and other quality-related incidents.
• Corrective and Preventive Actions: Coordinate CAPA activities, assess root causes, monitor implementation, and evaluate the effectiveness of corrective and preventive measures.
• Change Control: Assess proposed changes to pharmaceutical processes, equipment, materials, suppliers, systems, documentation, and product specifications for potential quality and compliance impacts.
• Quality Risk Management: Conduct or support risk assessments to identify potential product quality risks and recommend appropriate mitigation measures.
• Batch Documentation Review: Review batch manufacturing records, batch packaging records, and supporting documentation for completeness, accuracy, traceability, and compliance, where applicable.
• Supplier Quality Management: Support qualification, assessment, and monitoring of pharmaceutical manufacturers, raw material suppliers, contract service providers, and other quality-critical vendors.
• Audit Coordination: Coordinate quality audits, supplier audits, internal assessments, and external inspection preparation activities.
• Regulatory Inspection Support: Prepare quality documentation, evidence, responses, and corrective action plans to support regulatory inspections and compliance reviews.
• Product Quality Complaints: Review and coordinate investigations into product quality complaints, suspected defects, packaging issues, and other reported quality concerns.
• Product Quality Risk Assessment: Evaluate potential quality issues affecting product safety, identity, strength, purity, or overall suitability for use and coordinate appropriate escalation.
• Validation and Qualification: Review or coordinate documentation related to process validation, equipment qualification, cleaning validation, analytical method validation, and computerized system validation, as applicable.
• Quality Control Coordination: Collaborate with Quality Control teams on laboratory investigations, analytical discrepancies, out-of-specification results, and testing-related quality concerns.
• Training and Competency: Support quality-related training programs to ensure personnel understand applicable procedures, GMP principles, documentation requirements, and quality responsibilities.
• Quality Metrics and Reporting: Prepare reports covering deviations, CAPA status, audit findings, change controls, complaint trends, and other quality performance indicators.
• Regulatory Change Monitoring: Monitor relevant pharmaceutical quality regulations, guidance, and industry developments and assess their potential impact on quality systems.
• Continuous Improvement: Identify opportunities to improve documentation accuracy, investigation effectiveness, quality processes, and compliance performance.
• Remote Quality Coordination: Conduct virtual meetings, review controlled documentation electronically, track quality actions, and coordinate effectively with on-site pharmaceutical operations and distributed teams.

Qualifications and Experience

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, Chemical Engineering, or another relevant scientific discipline.
• At least 5–8 years of relevant experience in pharmaceutical quality assurance, quality systems, GMP compliance, or pharmaceutical quality management.
• Strong understanding of pharmaceutical quality management systems and applicable GMP requirements.
• Practical experience with deviation investigations, root cause analysis, CAPA, change control, and quality risk management.
• Knowledge of pharmaceutical documentation practices, data integrity principles, document control, and controlled record management.
• Experience supporting internal audits, supplier audits, regulatory inspections, and compliance remediation activities.
• Familiarity with pharmaceutical manufacturing, packaging, testing, batch documentation, and product release processes.
• Understanding of relevant international pharmaceutical quality standards and guidance, including applicable WHO, PIC/S, ICH, or other recognized frameworks.
• Familiarity with UAE pharmaceutical regulatory requirements and relevant quality compliance expectations.
• Experience reviewing or coordinating validation and qualification documentation, where applicable.
• Knowledge of supplier qualification, quality agreements, complaint handling, and pharmaceutical product quality risk assessment.
• Strong analytical, investigative, organizational, and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to prepare clear technical reports, investigation summaries, and quality documentation.
• Proficiency in Microsoft Office and familiarity with electronic quality management systems (eQMS), document management platforms, and quality reporting tools.
• Professional qualifications or training in GMP, quality management, auditing, risk management, or pharmaceutical quality assurance are advantageous.
• Ability to work independently, manage multiple quality activities, and coordinate effectively with on-site teams while maintaining a fully remote work arrangement.

Key Performance Indicators (KPIs)

Performance will be evaluated against agreed pharmaceutical quality, compliance, and operational objectives, including:

• GMP Compliance: Maintain alignment with applicable GMP requirements, approved procedures, and relevant quality standards.
• Deviation Management: Ensure deviations are documented, investigated, and resolved within established timelines.
• CAPA Effectiveness: Complete corrective and preventive actions on time and verify their effectiveness in addressing identified root causes.
• Change Control Performance: Ensure proposed changes are assessed, documented, reviewed, and approved according to established procedures.
• Documentation Accuracy: Maintain complete, accurate, traceable, and compliant quality records.
• Audit Readiness: Support successful audits and inspections through effective documentation management and timely follow-up.
• Quality Risk Management: Identify significant quality risks and support implementation of appropriate mitigation measures.
• Complaint Investigation: Ensure product quality complaints are assessed, investigated, and escalated appropriately.
• Supplier Quality Performance: Support effective supplier assessments and timely resolution of supplier-related quality issues.
• Training Compliance: Support timely completion of required quality and GMP training activities.
• Data Integrity: Maintain adherence to applicable data integrity principles and documentation standards.
• Quality Reporting: Deliver accurate quality metrics and management reports within agreed deadlines.
• Continuous Improvement: Contribute to measurable improvements in quality system effectiveness, investigation quality, and operational compliance.

What We Offer

• Competitive compensation based on qualifications and relevant experience.
• 100% remote working arrangement, allowing you to perform your responsibilities from home.
• Opportunities to contribute to pharmaceutical quality assurance and regulatory compliance initiatives.
• Professional development opportunities in GMP, quality systems, auditing, and pharmaceutical quality management.
• Exposure to pharmaceutical quality processes, risk management, supplier oversight, and regulatory inspection preparation.
• A collaborative environment that values scientific integrity, accuracy, accountability, and continuous improvement.
• Opportunities for career progression into pharmaceutical quality management, quality systems leadership, compliance, or regulatory quality roles.
• The opportunity to strengthen pharmaceutical quality standards and support reliable, compliant product operations.