Quality Assurance Manager

Role Overview

• Supports and strengthens the site’s Quality function by ensuring compliance with GMP, regulatory requirements, internal quality standards, and customer expectations
• Oversees day-to-day Quality Assurance (QA) activities depending on the organization’s structure
• Drives continuous improvement, maintains a strong quality culture, and ensures the consistent manufacture of safe, effective pharmaceutical products
• Leads Regulatory and External Customer Audits including preparation, execution and follow-up
• Maintains and continuously improves the site’s Quality Management System (QMS) in alignment with ISO 9001, ISO 15378, and other applicable regulations
• Ensures timely and compliant batch record review and product release processes
• Manages and develops QA staff, providing coaching, training, and performance evaluations.

Requirements

• Bachelor’s Degree required
• Science or engineering-related field a plus
• 5-7 years of relevant work experience, in a Q Manager/Engineer role
• Thorough knowledge of cGMP regulations and current industry practice
• Knowledge of ISO 9001 and ISO 15378
• Good knowledge of domain-specific legislation, standards rules and procedures
• Fluent in English, both verbal and written
• International travel propensity required
• Experience in customer-facing role desirable

Benefits

• Diversity and a wide range of career opportunities
• Interesting development opportunities with training and assignments in a global environment