Associate Director, Head of Quality

Description

• 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