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