Technical Manager

Role Overview

GSK is recruiting a Technical Manager to lead the technical functions at the pharmaceutical manufacturing site in Jeddah Warehouse City, Saudi Arabia. This is a key leadership role within the Site Leadership Team responsible for overseeing all technical aspects of the product lifecycle and ensuring full regulatory compliance.

Company Overview

GSK is a global biopharma company committed to supporting Vision 2030 and the Saudi Arabian National Agenda, including Saudization through the hiring and training and development of Saudi National capability. The company unites science, technology and talent to get ahead of disease together, aiming to positively impact the health of 2.5 billion people by the end of the decade.

Role Purpose

To lead the site technical function at Jeddah Warehouse City, provide strategic direction for technical activities across the product lifecycle, champion safety and quality compliance, and represent the site in regulatory interactions while ensuring all operations meet GMP requirements and SFDA standards.

Key Responsibilities

Leadership & Site Management

• Lead the site technical function at Jeddah Warehouse City and act as a core member of the Site Leadership Team, contributing to overall site performance and delivery of business goals within a GMP framework.
• Drive proactive talent management within the technical team, including succession planning, capability building and support for graduate and industrial placement programmes.

Technical Strategy & Operations

• Provide strategic direction for technical activities across the product lifecycle, ensuring robust technical support for manufacturing operations and product-related decisions.
• Ensure manufacturing operations follow GMP requirements, including approval of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
• Authorise site quality improvement plans, technical change controls (facilities, production lines, product components) and annual product review reports.
• Provide finished product batch release during the absence of the Quality Lead and authorise any reprocessing/rework requests as required.

Compliance & Quality Management

• Champion safety, quality, and compliance, embedding GMP and QMS principles in daily operations and long-term improvement plans.
• Approve quality risk assessments, incident/deviation management and associated CAPAs, and ensure robust documentation and governance.
• Review and approve the self-inspection plan (Inspection Audit Universe), and audit and CAPA reports generated by relevant departments.

Regulatory & Audit

• Represent the Jeddah Warehouse City site in interactions with SFDA, Ministry of Health (MOH) and other regulatory bodies on matters related to licensing, inspections, and regulatory submissions.
• Lead and front regulatory and internal audits; ensure effective follow-up, alignment of Level 2 processes, and implementation of CAPAs to sustain and improve compliance.
• Oversee preparation, review and approval of technical registration documentation and product files submitted to SFDA and other authorities.

Product & Risk Management

• Hold formal responsibility for product recalls and complaints, coordinating with relevant departments to secure timely corrective and preventive actions.

Qualifications & Experience

• Bachelor's degree in Pharmacy or Doctor of Pharmacy (PharmD).
• Proven experience in a senior technical or leadership role within pharmaceutical manufacturing, or at the interface of R&D and manufacturing.
• Minimum of 3 years' experience in a pharmaceutical manufacturing environment.
• Strong track record in leading technical teams and delivering technical solutions in a GMP setting.
• Excellent knowledge and practical application of GMP guidelines and Quality Management System (QMS) requirements.
• Saudi national, in line with local regulatory and licensing requirements.
• Valid practitioner licence from the Saudi Commission for Health Specialties and compliance with SFDA requirements.

Skills & Competencies

• Demonstrated ability to drive change, deliver solutions, and develop people in a complex, matrixed environment.
• Strong knowledge of regulatory requirements and pharmaceutical product development.
• Solid operational understanding of manufacturing unit operations, plant and laboratory equipment.
• Strong analytical skills with the ability to interpret data and use it for tactical and strategic decision-making.
• Excellent communication and influencing skills at all levels of the organisation and with external regulators.
• CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer.
• High level of proficiency in English (spoken and written).