Technical Manager – Quality & Regulatory Leadership
Julphar
وصف الوظيفة
About the role
The Technical Manager will lead all technical and quality functions at the plant, ensuring compliance with Saudi FDA (SFDA) regulations and international standards. This senior position is responsible for overseeing supplier approvals, process validation, and continuous improvement of the Quality Management System.
Key responsibilities
- Technical & Quality Leadership: manage technical departments, approve suppliers, technical agreements, building and production line changes, and product variations.
- Regulatory & Compliance: ensure adherence to cGMP, GLP, GDP and SFDA requirements; represent the plant during SFDA inspections; approve audit responses and CAPA plans.
- Operational & Strategic Management: qualify raw material and packaging suppliers, drive technology transfer, conduct internal audits and management reviews.
- Leadership & Staff Development: define roles, assess competency gaps, implement training, and evaluate performance.
- Recall & Investigation Management: lead product recall investigations and coordinate with QA.
- Environmental, Health & Safety: follow ISO 14001:2015 EMS and Saudi safety guidelines (NCOSHA, SASO, OSH, NEBOSH).
Required profile
- Extensive experience in technical and quality management within a regulated manufacturing environment.
- Strong knowledge of Saudi FDA (SFDA) regulations and international standards (cGMP, GLP, GDP).
- Proven ability to lead cross‑functional teams and drive continuous improvement.
- Excellent analytical and problem‑solving skills for investigations, recalls and CAPA.
Required skills
- Quality Management System (QMS) implementation and improvement
- Process validation and equipment qualification
- Change control and supplier qualification
- cGMP, GLP and GDP compliance
- ISO 14001:2015 Environmental Management System
- HSE compliance (NCOSHA, SASO, OSH, NEBOSH)
Questions fréquentes
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اكتشف المزيد
الرواتب والأدلة وعمليات البحث في المملكة العربية السعودية.
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Julphar
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