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À propos de ce poste Operation Quality Section Head chez GSK

GSK · Sur site · Egypt - Cairo

Scope:


Supervising the OQ activities related to the release of manufactured batches, ensuring compliance with Good Manufacturing Practices (GMP), Corporate Quality Standards, and local/international regulations. The role ensures the execution and continuous improvement of quality systems, deviation investigations, audit readiness, and operational quality oversight across the Value Stream.


Key Responsibilities:
In this role, you will be responsible for the following:


Quality Oversight & Compliance


  • 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.

Quality Systems & Performance Management


  • 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.

Batch Release & Authorized Person Responsibilities


  • 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.

Leadership & Team Development


  • 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).



Key Capabilities and Skills:


  • Up to date knowledge of current GMP, EDA Regulatory requirements, QMS System.
  • Excellent documentation, report writing skills, and computer skills.
  • Excellent verbal and written communication skills.
  • Excellent problem solving and critical thinking capabilities.
  • Strong prioritization and organization skills.
  • Familiar with IQ, OQ, PQ, facility, utilities, Equipment and Strong experiences in cGMP/GLP compliance activities.
  • Self-motivation, empowerment and adaptation to business changes.
  • Able to demonstrate experience of managing diverse teams of professional staff and effective budgetary control against agreed targets.

This role is fully on site.



Application Closure Date: 17 November 2026



Please submit your CV in English.


Please take a copy of the Job Description, as this will not be available post closure of the advert. 
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.


Skills

Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical Writing

 

 

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

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.

Contact information:
You may apply for this position online by selecting the Apply now button.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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À propos de GSK

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel i

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