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 Senior Pharmaceutical Quality Specialist to support pharmaceutical quality management systems, regulatory compliance, quality assurance activities, and continuous improvement initiatives. The role focuses on reviewing quality documentation, monitoring compliance with Good Manufacturing Practice (GMP) and other applicable standards, coordinating deviation and CAPA processes, and supporting audit and inspection readiness. Working remotely, the specialist will collaborate with quality assurance, quality control, manufacturing, regulatory affairs, supply chain, and external manufacturing partners to maintain robust pharmaceutical quality standards.

Key Responsibilities

• Support the development, implementation, maintenance, and continuous improvement of pharmaceutical quality management systems.
• Review and assess SOPs, batch documentation, validation records, specifications, quality agreements, and other controlled documents.
• Monitor compliance with applicable GMP, Good Distribution Practice (GDP), and relevant pharmaceutical quality requirements.
• Coordinate the review and documentation of deviations, non-conformances, out-of-specification events, and quality incidents.
• Support root cause analysis and the development, tracking, and effectiveness verification of corrective and preventive actions (CAPA).
• Review change control requests and assess potential impacts on product quality, validated processes, documentation, and regulatory commitments.
• Monitor quality metrics, recurring deviations, complaint trends, and process performance indicators.
• Support supplier and contract manufacturing organization quality oversight through documentation reviews, performance assessments, and remote quality meetings.
• Review supplier qualification records, audit reports, quality agreements, and corrective action responses.
• Coordinate internal and external audit preparation, documentation requests, and follow-up activities.
• Support regulatory inspection readiness by maintaining organized quality records and tracking outstanding compliance actions.
• Review product quality complaints, investigation summaries, and proposed corrective measures.
• Assist with product quality risk assessments and the evaluation of potential impacts on patient safety and product compliance.
• Support validation and qualification documentation reviews, including process validation, cleaning validation, equipment qualification, and computerized system validation.
• Monitor training compliance and support the maintenance of role-based quality training records.
• Review documentation associated with product release processes while ensuring that formal batch disposition remains with authorized quality personnel.
• Coordinate quality-related communication between manufacturing, laboratory, regulatory, and supply chain stakeholders.
• Prepare quality reports, management review summaries, audit dashboards, and compliance performance updates.
• Identify opportunities to strengthen documentation practices, quality controls, and operational consistency.
• Provide technical guidance to junior quality team members and support consistent application of quality procedures.

Qualifications and Experience

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Life Sciences, or a related discipline.
• Significant experience in pharmaceutical quality assurance, quality systems, GMP compliance, or pharmaceutical manufacturing quality.
• Strong knowledge of GMP principles and relevant pharmaceutical quality standards and regulatory expectations.
• Experience working with deviations, CAPA, change control, non-conformance management, and quality risk assessments.
• Familiarity with pharmaceutical documentation, batch records, product specifications, validation protocols, and quality agreements.
• Understanding of supplier qualification, contract manufacturing oversight, and pharmaceutical supply chain quality controls.
• Experience supporting internal audits, supplier audits, regulatory inspections, and compliance remediation activities.
• Knowledge of data integrity principles, including ALCOA+ expectations and controlled electronic records.
• Familiarity with electronic quality management systems (eQMS), document management platforms, and quality reporting tools.
• Ability to review technical quality records and identify documentation gaps, compliance risks, and recurring quality issues.
• Strong analytical, investigation, and problem-solving capabilities.
• Excellent written communication and technical documentation skills.
• High standards of accuracy, confidentiality, and professional judgment.
• Ability to work independently and coordinate with cross-functional teams in a fully remote environment.
• Relevant professional certifications or postgraduate qualifications in pharmaceutical quality, GMP, or quality management are an advantage.

What We Offer

• A fully remote, work-from-home position based in the UAE.
• The opportunity to support pharmaceutical quality systems and regulatory compliance initiatives.
• Exposure to GMP quality assurance, supplier oversight, validation documentation, and continuous improvement projects.
• Collaboration with pharmaceutical manufacturing, quality control, regulatory affairs, and supply chain professionals.
• Opportunities for professional development in pharmaceutical quality management.

How to Apply

Interested candidates should submit an updated CV highlighting their pharmaceutical quality assurance experience, GMP knowledge, quality management system expertise, and relevant professional qualifications.

Application Subject: Application – Senior Pharmaceutical Quality Specialist (UAE Remote)

Candidates should confirm applicable employment arrangements, UAE residency requirements, and work authorization before accepting an offer.

• Role Scope: This is a remote pharmaceutical quality systems, documentation review, and technical oversight position. Physical manufacturing activities, laboratory testing, sampling, equipment operation, facility inspections, and on-site quality checks must be performed by qualified local personnel. Final batch release, product disposition, regulatory submissions, statutory certifications, and other regulated quality decisions must be completed or approved by appropriately authorized professionals in accordance with applicable requirements.