Our client, a leader in advanced therapies, seeks a seasoned professional to oversee GMP, GCP, and GLP Quality functions. This senior leadership role ensures compliance with GxP regulations, drives continuous improvement, and involves collaboration across teams and presentations to the board of directors.

Key Responsibilities:

• Leadership & Strategy: Define and execute the vision, strategy, and budget for QA/QC functions.
• Regulatory Compliance: Ensure adherence to FDA, EMA, ICH, and related guidelines. Lead inspections, audits, and quality assessments.
• Quality Systems: Implement and maintain robust QMS, updating SOPs and policies.
• Risk Management: Lead initiatives to mitigate risks and address product quality issues.
• GxP Oversight: Ensure compliance in GMP manufacturing, clinical trials (GCP), and preclinical studies (GLP).
• Travel: Up to 20% travel required.

Qualifications:

• 10 years experience, with 5+ years in senior leadership roles.
• Deep expertise in GxP regulations and biologics, with cell and gene therapy preferred.
• Proven success in QA/QC oversight for early clinical development.
• Experience with GMP manufacturing, risk management, and quality systems.