Oversee GMP compliance and quality management in innovative cell and gene therapy production. Lead strategic compliance initiatives within a collaborative environment.
As the Director of Quality Compliance, you will be at the forefront of ensuring quality in a state-of-the-art manufacturing facility. Your responsibilities include managing compliance programs, addressing auditor requirements, and supporting risk management processes. Close collaboration with multiple departments will enhance overall productivity and operational effectiveness.
Key Responsibilities:
• Lead CAPA and manufacturing change control
• Manage training and customer complaint responses
• Drive audit programs and data integrity initiatives
• Supervise internal audits and regulatory inspections
• Ensure compliance with GMP standards across operations
Requirements:
• Bachelor’s degree in a relevant field
• 10–20 years of industry experience required
• In-depth knowledge of GMP and reg...