About the role

AI summarised

The Quality Assurance Manager is responsible for ensuring the affiliate implements and maintains cost-effective quality systems solutions while remaining in compliance with all regulatory requirements. This role provides integrated QA support for the EPD Supply Chain, manages quality metrics, handles complaints, and oversees audit programs.

HealthcareOnsite

Key Responsibilities

Implement and manage local quality systems, including CAPA, complaint handling, inspection reporting, policy implementation, supplier management, and document/change control.
Develop and maintain the Quality Management System Manual while ensuring compliance with all regulatory and business requirements.
Serve as the key Affiliate contact for internal audits and Regulatory Authority inspections.
Provide integrated QA support for EPD Supply Chain issues and manage the First Lot Quality Review program for product launches.
Ensure all distributed products conform to current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and applicable regulatory standards.
Manage local over-labeling/redressing activities ensuring compliance with GMP and regulatory standards.
Manage the lifecycle of quality complaints, from registration via SolTRAQs to final closure and communication with complainants.
Manage Internal Audit/self-inspection programs at the Commercial Affiliate to ensure quality system effectiveness.

Requirements

Bachelor of Science degree or equivalent.
Minimum 4-5 years of quality assurance experience in the pharmaceutical industry.
Proven ability to take the lead in driving projects and initiatives.
Fluent English proficiency (written and oral) to communicate across all management levels.
Strong interpersonal, negotiation, and stakeholder management skills.
Executive presence suitable for participating in Leadership meetings.