Role Purpose
The role is responsible for ensuring that the company’s quality management system and local regulatory requirements in Egypt are fully implemented and maintained across commercial operations. The job holder will support the deployment of quality standards, monitor performance, and drive continuous improvement in line with internal procedures and applicable regulations.
Key Responsibilities
- Act as a quality management system champion in Egypt by supporting implementation, performing gap assessments where needed, and coordinating relevant quality forums.
- Support the development and execution of the annual quality plan for Egypt in alignment with regional objectives and in collaboration with the quality manager.
- Monitor quality performance indicators for Egypt, ensuring targets are met and improvement plans are defined and followed where required.
- Contribute to the preparation of quality council meetings, including compiling materials and documenting meeting minutes.
- Participate in regional quality meetings and support preparation as needed.
- Implement and maintain effective quality assurance systems in Egypt to ensure compliance with company standards, policies, regulatory requirements, and good storage and distribution practices, including:
- Managing the self-inspection program (defining scope, scheduling, conducting inspections, issuing reports, and following up corrective and preventive actions).
- Managing the third-party warehouse audit and approve distributers for both ambient and cold chain conditions.
- Coordinating change control activities, including assessment of proposed changes and follow-up of related actions.
- Managing deviation handling related to imported products and local storage/distribution, including root cause analysis and corrective/preventive actions.
- Overseeing corrective and preventive action (CAPA) management, including development, agreement, follow-up, and closure.
- Acting as owner of the customer complaint process in Egypt, including data and sample collection, liaison with manufacturing sites for investigation, and provision of appropriate feedback; reviewing trends and supporting actions on recurring issues.
- Supporting incident and recall management in Egypt, including investigation, impact assessment, and coordination of product disposition and recall execution when needed.
- Overseeing quality release of imported finished products and reviewing/approving overprinting and repacking activities.
- Identify and assess risks related to quality management activities and escalate them to relevant quality councils and governance bodies, ensuring mitigation plans are developed and followed.
- Act as owner of internal quality agreements between supplying sites and the local organisation, including establishment, updates, and maintenance.
- Establish and maintain quality agreements with third-party manufacturers, service providers, and distributors, and conduct audits on third-party contractors to ensure compliant storage and distribution of products.
- Lead quality regulatory intelligence activities in Egypt, ensuring that regulatory updates are assessed, gaps are addressed through corrective and preventive actions, and relevant stakeholders are informed.
- Manage quality alerts in Egypt, including acceptance/rejection, assessment of impact, and development of actions to close identified gaps.
- Prepare the local quality organisation for regulatory inspections, ensuring all regulatory and good practice requirements are met.
Qualifications
- Bachelor’s degree in pharmacy.
- Minimum of 5 years of relevant experience.
- Fluent in English (written, spoken, and read).
- Proficient computer skills.
Skills and Competencies
- Strong understanding of quality management systems and their implementation.
- Solid experience in quality assurance systems, particularly deviation handling, change control and management, self-inspection, CAPA management, and finished goods storage and distribution.
- Strong knowledge of good distribution and good storage practice requirements.
- Very good communication skills.
- Good leadership abilities, analytical thinking, and problem-solving skills.
- Strong observation skills; auditing experience is preferred.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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.
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