Associate Director, Quality

About the role

This position manages quality assurance activities, provides strategic oversight of the implementation of a Quality Management System (QMS), and ensures compliance with FDA, ICH, and other regulatory standards. The Associate Director of Quality ensures compliance with GxP regulations (GLP, GMP, GCP as applicable) across our CROs, establishes quality frameworks, and leads quality initiatives that support the company's pipeline from preclinical research through clinical development in a fast-paced, resource-conscious environment.

Responsibilities

• 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.
• 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.
• 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.

Requirements

• Bachelor’s degree in life sciences or related field required.
• 10+ years of biotech industry experience.
• Previous startup or small company experience highly preferred.
• Experience building quality processes in early-stage development and understanding a fit-for-purpose approach.
• Minimum 3-5 years of experience managing CROs and vendor relationships.

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.
• Excellent leadership, communication, and interpersonal skills.

Pay

The salary range for this temporary position is $80.00 to $93.00 USD per hour. The actual salary may vary based on factors such as individual education, experience, tenure, skills, abilities, internal equity, and geographic location.