Description

You will manage quality support for the primary and secondary distribution of commercial and EUA drug products.

Responsibilities

• Oversee third-party logistics (3PL) companies to ensure distribution quality and compliance.
• Develop and maintain Quality Agreements with suppliers and 3PL providers.
• Support serialization implementation initiatives and participate in relevant audits.
• Monitor 3PL distribution metrics and report quarterly for Management Review.
• Author and update SOPs and identify risks within GMP processes and systems.

Required Skills

• Bachelor’s Degree with at least 5 years of experience, or a Master’s degree with 3 years of experience in the pharmaceutical/biotech industry.
• Experience in a biotech or pharmaceutical development environment.
• Knowledge of cGMP quality systems and 3PL management.
• Working knowledge of FDA, EU, and ICH guidelines and regulations.
• Proficiency in writing and updating SOPs.
• Ability to manage multiple projects and communicate complex issues clearly.
• Experience collaborating in cross-functional matrix environments.

Preferred Skills

• Project management experience.

Key Skills

Education

Bachelor’s Degree