Quality Head
Job Fit Check
Base Career helps you apply smarter for this job.
Key skills for this role
About the Role
Lead Quality organization, establish Quality Management System, ensure compliance with regulations, and promote patient safety in pharmaceutical manufacturing.
Key Skills for This Role
Responsibilities
- Establish the Quality System within the organization through implementation of Quality System elements
- Lead site Quality functions from project stage to commercial operations
- Establish and maintain QMS including Change Control, Deviations, CAPA, and Quality Risk Management
- Establish quality system for qualification and validation of sterile injectable manufacturing facility
- Manage Quality Training Program and Vendor Management Program
- Review and approve Site Master File, Validation Master Plan, SOPs, and APQRs
- Ensure compliance with Saudi FDA requirements and host regulatory inspections
- Lead recruitment of QA and QC personnel
- Ensure Environmental Monitoring, Media Fill, and Sterility Assurance programs are implemented
- Promote a Quality First culture ensuring patient safety and product quality
Requirements
- Minimum 18 years of experience in sterile injectable and/or biosimilar pharmaceutical manufacturing
- Experience establishing and maintaining Pharmaceutical Quality System and QMS
- In depth knowledge of SFDA regulations and GMP requirements
- Experience with qualification and validation of sterile injectable manufacturing facilities
- Strong leadership and team management skills
Full Job Posting
Role Overview
- Head of Quality position in Saudi Arabia.
- Minimum 18 years of experience in sterile injectable and/or biosimilar pharmaceutical manufacturing.
- Lead the overall Quality organization from project stage through commercial operations.
Key Responsibilities
- Establish the Quality System within the organization through implementation of Quality System elements.
- Lead the site Quality functions from the project stage to commercial operations.
- Establish and maintain the Quality Management System (QMS), including Change Control, Deviations, Investigations, CAPA, Self Inspection, and Quality Risk Management (QRM).
- Establish the quality system for qualification and validation of the sterile injectable manufacturing facility.
- Establish and manage the site Quality Training Program and Vendor Management Program.
- Provide guidance for qualification and validation of manufacturing and QC equipment (URS, DQ, FAT, SAT, IQ, OQ, PQ).
- Review and approve Site Master File, Validation Master Plan, SOPs, APQRs, STPs, GTPs, and Quality Technical Agreements.
- Review and approve all Stability Study Programs and support Regulatory Affairs in submissions.
- Monitor Quality metrics and report performance trends to Management.
- Ensure compliance with Saudi FDA requirements and host regulatory inspections.
- Ensure implementation of analytical method transfers and effectiveness of QMS for secondary packaging.
- Lead recruitment of QA and QC personnel and promote a Quality First culture.
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at 3 Point Hrm
Quality Head
Saudi Arabia, KSA
Establish the Quality System within the organization through the implementation of Quality System elements. Lead the site Quality functions from the project stage to commercial ...
Digital Transformation and Cyber Security Lead
Saudi Arabia, KSA
Responsible for IT security in digital transformation and cyber security, requiring a postgraduate degree and expertise in IT services and consulting.
Head-SCM
Saudi Arabia, KSA
Responsible for supply chain management and logistics in IT services, requiring a postgraduate degree and expertise in procurement.