Senior Director Quality Operations

About the role

The Senior Director of Quality Operations will lead the integrated Quality Assurance and Quality Control functions for a leading pharmaceutical manufacturer in Pakistan. Reporting to senior management, this executive ensures that all products meet the highest standards of safety, efficacy, and regulatory compliance.

Key responsibilities

• Oversee both QA and QC departments, driving continuous improvement across all quality processes.
• Develop, implement, and maintain the Quality Management System (QMS) in line with global standards.
• Lead validation activities, stability studies, and quality audits.
• Manage CAPA programs, ensuring timely root‑cause analysis and corrective actions.
• Ensure compliance with local and international regulatory requirements.
• Collaborate with Regulatory Affairs to support product registrations and submissions.

Required profile

• B‑Pharm, Pharm‑D or MSc from a reputable university.
• 15–20 years of experience in the pharmaceutical industry.
• 4–5 years of experience in a Director‑level Quality Operations role.

Required skills

• Quality Management System (QMS) implementation.
• Validation and stability study expertise.
• Conducting quality audits.
• CAPA management.
• Regulatory compliance and affairs knowledge.
• Proficient computer skills.