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GSK

Develops medicines, vaccines, and consumer health

Operation Quality Section Head

Regulatory & Quality (Life Sciences)Posted on Nov 10
Full-timeCairo, Cairo Governorate, EgyptNo salary listed

About the Job

Requirements

  • A university degree in Pharmacy or a scientific discipline is required.
  • At least five years of experience in Quality Assurance or operational roles within the pharmaceutical industry is required.
  • Previous people management experience is required.
  • Fluency in written and spoken English and Arabic is required.
  • Current knowledge of Good Manufacturing Practices, EDA regulatory requirements, and Quality Management Systems is required.
  • Documentation, report writing, and computer skills are required.
  • Verbal and written communication skills are required.
  • Problem-solving and critical-thinking capabilities are required.
  • Prioritization and organizational skills are required.
  • Familiarity with IQ, OQ, PQ, facilities, utilities, and equipment is required, along with strong experience in cGMP and GLP compliance activities.
  • Experience managing diverse teams of professional staff and effective budgetary control against agreed targets is required.

Responsibilities

  • 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 Good Manufacturing Practices compliance.
  • Monitor oversight coverage, execution, overdue activities, and related actions.
  • Evaluate oversight effectiveness and drive continuous improvement.
  • Ensure implementation and compliance with site Quality Management Systems, Good Manufacturing Practices, GMS, and regulatory requirements.
  • Lead and oversee deviations, out-of-specification and out-of-trend investigations, complaints, corrective and preventive actions, quality incidents, rework, and reprocessing activities, ensuring robust investigations and timely closure.
  • Drive quality performance improvement through monitoring site key performance indicators, quality trends, periodic system reviews, and Quality Improvement Programs.
  • 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 and SLE activities, and support GPS foundations.
  • Escalate critical quality issues and ensure effective resolution.
  • Oversee and perform batch release activities for manufactured and packaged products, ensuring full Good Manufacturing Practices and regulatory compliance.
  • Review and approve batch documentation, including Batch Manufacturing Records, Batch Packaging Records, specifications, bills of materials, and relevant quality records.
  • Ensure completion and assessment of required manufacturing, quality control, sampling, testing, change control, and deviation activities before batch release.
  • Perform Authorized Person batch release activities and relevant enterprise resource planning transactions, including release, rework, and rejection decisions.
  • Oversee Authorized Person delegate qualification, where applicable.
  • Monitor and report conformance to the release plan and maintain accurate SAP quality-related data.
  • 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.

About the Company

GSK

Develops medicines, vaccines, and consumer health

GSK is a global healthcare company focused on three main areas: Pharmaceuticals, Vaccines, and Consumer Healthcare. It develops medicines, vaccines, and consumer health products to improve health outcomes worldwide. Its products address diseases in respiratory, HIV, oncology, and immuno-inflammatory areas; vaccines for influenza, shingles, and COVID-19; and over-the-counter wellness products. The company relies on substantial R&D and strategic partnerships to bring new products to market and to address health needs. Revenues come from sales of medicines, vaccines, and consumer health items, often complemented by patient support programs and collaborations with governments and biotech partners.

Company size
10,001+
Company stage
IPO
Headquarters
London, United Kingdom
Founded
1891

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