Associate Director, Quality

What You Will Do

• Quality Program Development
• Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, GCP).
• Implement pragmatic quality approaches that balance compliance with operational efficiency.
• Create quality culture and awareness across all organizational levels.
• Excellent leadership, communication, and interpersonal skills.
• CRO Management & Strategic Partnerships
• Serve as the co-primary quality liaison for CDMO partnerships, overseeing quality agreements, audits, and ongoing compliance activities.
• Implement risk-based CRO oversight programs optimized for resource efficiency.
• Build strong working relationships with CRO quality teams to ensure seamless collaboration.
• Manage CRO performance with emphasis on speed, quality, and value delivery.
• Quality Systems & Documentation
• Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, GCP).
• Ensure proper documentation and record-keeping practices.
• Lead development of standard operating procedures (SOPs) and work instructions.
• Maintain document control and change management processes.
• Review key quality documentation, including protocols, reports, SOPs, batch records, and laboratory data.

Technical Requirements and Skills

• Deep understanding of FDA, EMA, & ICH regulatory requirements.
• Extensive knowledge of GMP, GLP, and GCP principles.
• Experience with quality management systems and quality metrics.
• Strong understanding of gene therapy development processes.
• Experience with quality auditing and inspection processes.

Qualifications

• Bachelor's degree in life sciences or related field required.
• 10 + years of biotech industry experience.
• Previous startup or small company experience highly preferred.
• Minimum 3-5 years of experience managing CROs and vendor relationships.