Operation Quality Section Head

Scope:

• →Drive and strengthen quality culture across all value stream operations.
• →Define and maintain the scope and risk-based frequency of Quality Oversight activities across manufacturing, processing, packaging, and supporting functions.
• →Supervise OQ Officers in executing routine oversight activities and ensuring GMP compliance.
• →Monitor oversight coverage, execution, overdue activities, and related actions.
• →Evaluate oversight effectiveness and drive continuous improvement.
• →Ensure implementation and compliance with site QMS, GMP, GMS, and regulatory requirements.

• →Oversee and perform batch release activities for manufactured and packaged products, ensuring full GMP and regulatory compliance.
• →Review and approve batch documentation, including BMRs, BPRs, specifications, BOMs, and relevant quality records.
• →Ensure completion and assessment of all required manufacturing, QC, sampling, testing, change control, and deviation activities before batch release.
• →Perform Authorized Person batch release activities and relevant ERP transactions, including release, rework, and rejection decisions.
• →Oversee AP delegate qualification, where applicable.
• →Monitor and report conformance to release plan and maintain accurate SAP quality-related data.

• Lead and oversee deviations, OOS/OOT investigations, complaints, CAPAs, quality incidents, rework, and reprocessing activities, ensuring robust investigations and timely closure.
• Drive quality performance improvement through monitoring of site KPIs, quality trends, periodic system reviews, and Quality Improvement Programs (QIPs).
• Prepare and present periodic quality performance and system reviews to the Site Quality Council.
• Review and approve relevant quality risk assessments, product lifecycle activities, validation documents, and periodic product reviews.
• Manage and coordinate product quality incidents with relevant site quality functions.
• Drive inspection readiness through GEMBAs, SLE activities, and support of GPS foundations.
• Escalate critical quality issues and ensure effective resolution.

• Lead, coach, and develop direct reports, ensuring appropriate technical competencies, training, and qualifications.
• Monitor team performance and promote accountability, collaboration, and continuous improvement.
• Build effective cross-functional partnerships to achieve site quality objectives
  
  

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• University Degree in Pharmacy or Scientific disciplines.
• Minimum five years of experience in Quality Assurance, or Operational roles within the Pharmaceutical industry.
• Previous people management experience.
• Fluency in English and Arabic (both written and spoken).

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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