Manage all technical- related functions and departments within the plants as per the SFDA Guidelines.
Final approval of suppliers of semi-finished/ Raw Material and packaging materials, technical agreements for outsourcing activities and all changes of building, utilities, production lines and products variation
Oversee the implementation, monitoring, and continuous improvement of the Quality Management System (QMS).
Review and approve critical quality and technical documentation (e.g., Site Master File, Quality Manual, Validation Master Plan).
Approve process validation, equipment qualification, and change control activities.
Authorize investigations related to deviations, out-of-specifications (OOS), and product complaints.
Manage product recall processes and ensure proper documentation and corrective actions.
Final approval of the organogram and the job description.
Regulatory & Compliance
Ensure full adherence to cGMP, GLP, GDP, and SFDA regulatory requirements.
Responsible for representing the plant during the SFDA inspection along with the QA.
Approve responses and CAPA plans related to internal, external, and regulatory audits.
Oversee management of controlled and narcotic substances in compliance with Saudi regulations.
Ensure accuracy and completeness of all technical documents submitted for product registration and renewal.
In Case of Recall, Responsible to manage the investigation the Recall Process in coordination with the QA department.
Operational & Strategic Management
Approve supplier/vendor qualifications for raw materials, packaging materials.
Ensure proper execution of technology transfer and product lifecycle management activities.
Conduct internal audits and management reviews to assess QMS performance and drive continual improvement.
Leadership & Staff Development
Define roles, responsibilities, and performance expectations for technical staff.
Identify competency gaps and implement training and development programs.
Evaluate employee performance and promote a culture of accountability, quality, and safety.
Foster effective communication and collaboration across technical and quality functions.
Additional Duties:
Prepare and present technical and operational performance reports for senior management.
Support external audits, inspections, and regulatory visits.
Perform any other job-related duties as assigned in line with business needs.
Environmental, Health and Safety Responsibilities:
Follow the company's Environmental Management System (ISO 14001:2015) and HSE policies in daily work.
Follow and ensure compliance with Saudi Safety Guidelines like, NCOSHA, SASO, OSH, NEBOSH,
Actively minimize environmental impacts, maintain a safe workplace, and handle tasks responsibly (e.g. proper disposal of waste, safe use of equipment).
Report hazards, non-conformities, or environmental issues to supervisors and support continual improvement initial.
Core Competency
In terms of competency, you are highly result-oriented with an intense sense of accountability & ownership.
High compliance adherence, having strong diligence, initiative-taking, and flexibility.
Excellent communication, interpersonal, and collaboration skills.
Having demonstrated skills in leadership and people management
Must be able to manage tasks, plan workload effectively, prioritize, and easily adapt to changing situations.
Identify, reduce, and prevent environmental impacts and operational risks.
Contribute to EHS activities, audits, and continual improvement initiatives.
Qualification/Functional Knowledge
Education: Bachelor's or Doctorate degree in Pharmaceutical Sciences / Pharmacy (B.Pharm or PharmD) – mandatory as per SFDA regulations
Experience: Minimum 10 years in pharmaceutical manufacturing, quality assurance, or related technical fields, including leadership experience in a cGMP-regulated environment, with minimum 5 years of Similar Role
Comprehensive understanding of GMP, GDP, ISO 9001 and ISO 14001 requirements.
Strong familiarity with regulatory guidelines (e.g. SFDA, FDA, WHO, EU).
Experience in audits, CAPA, risk management, and QMS systems.
Excellent leadership and team management skills.
Analytical thinking and problem-solving skills.
Proficiency in MS Office and electronic QMS platforms
