Description

You will oversee quality operations and ensure compliance with cGMP/GDP requirements for partner blood banks and testing labs.

Responsibilities

• Provide daily oversight of quality operations to ensure adherence to cGMP/GDP requirements.
• Support partner blood banks and testing labs in maintaining regulatory compliance.
• Guide and advise colleagues on GMP-compliance standards.
• Execute change control processes.
• Collaborate with suppliers to implement and manage quality programs.

Required Skills

• 3+ years of experience in quality assurance or a related role.
• Bachelor's degree in biomedical or life sciences.
• Working knowledge of FDA-CFR Title 21 and EU regulations.
• Familiarity with international, US, state, and local cGMP and GDP guidelines.
• Experience managing change control processes.
• Understanding of quality systems and quality management programs.
• Strong written and verbal communication skills.
• Proven ability to manage multiple tasks and address compliance issues through problem-solving.

Preferred Skills

• Experience with supplier quality programs.

Key Skills

Education

Not specified