Quality Assurance

•       Oversee QA operations, including batch release, complaint handling, and cGMP compliance.

•       Represent the site during customer audits and regulatory inspections.

•       Collaborate with cross-functional teams to ensure quality standards in manufacturing.

Quality Control

•      Lead QC functions covering Raw Material, Analytical, Microbiology, Biochemistry, and Environmental Monitoring.

•       Ensure timely testing and release of results, including Certificates of Analysis.

•       Develop and implement QC strategies aligned with business goals.

Quality Compliance

•       Implement and maintain procedures in alignment with global and national cGMP regulations.

•       Translate global quality standards into site-level policies and practices.

•       Maintain site readiness for audits and certifications.

Customer Interface

•       Ensure all quality related customer complaints are investigated and handled in time.

•       Develop insights that can be used to enhance customer satisfaction or other metrics.

•       Identify when company and customer interest may not align and seeks effective solution to resolve or escalate.

Regulatory Affairs

•       Keep the site updated with the recent applicable regulations.

•       Coordinate with all functions to ensure site compliance with the latest requirement and monitor execution of the related action plan.

Strategy & Continuous Improvement

•       Develop long-term and annual quality plans.

•       Lead quality improvement projects in line with the Operational Excellence strategy.

•       Drive strategic initiatives to strengthen quality systems and processes.

Resource Planning

•       Manage department budgets, staffing, and scheduling.

•       Ensure adequate resources are available to meet business and regulatory demands.

•       Prioritize quality initiatives to meet critical timelines.

People & Leadership

•       Build and lead a high-performing quality team across QA, QC, and Compliance.

•       Implement team development, training, and succession plans.

•       Foster a compliant, efficient, and collaborative team culture.

Qualifications   

•       Degree :Master degree,

•       Field of Study: Pharmacy, Chemistry, Biotechnology, Engineering

•       English: Business Fluent

•       Highly Experienced (10+ years) in Leading Senior Quality Function.

•       People management skills

•       Strong communication skills (vocal/written/presentation)

•       Strong execution skills (ability to plan and take activities to closure)

•       Project management skills

•       Strong analytical skills