Senior Quality Assurance Delegate (On-site, Valby)

Job summary

This role involves ensuring compliance with GMP and GDP standards for investigational medicinal products in clinical trials. The Senior Quality Assurance Delegate is responsible for batch certification, managing deviations, and overseeing external vendors while promoting continuous improvement in quality systems.

Qualifications

• Minimum of 5 years as a QP delegate, preferably in CMC.
• At least 10 years in a GMP-regulated environment within Quality Assurance, Manufacturing, or Quality Control.
• Expertise in QA processes including deviation management and change control.
• Proficient in batch record review for biologics and small molecules.
• Experience with vendor oversight and quality agreements.
• Strong problem-solving and decision-making skills.

Responsibilities

• Ensure compliance with applicable GMP and GDP requirements.
• Certify batches and assess deviations and complaints.
• Mentor colleagues in risk assessment and quality decision-making.
• Serve as process owner for defined workstreams, ensuring regulatory compliance.
• Collaborate with Product Quality Leads and stakeholders across various departments.

Skills

• Strong risk-based decision-making capabilities.
• Ability to manage complex projects with maturity and prioritization.

Education

• Relevant degree in life sciences or related field preferred.

Tools

• Familiarity with quality management systems and regulatory compliance tools.