Associate Director, Quality

The Role:

The Associate Director of Quality is responsible for managing quality assurance activities, providing strategic oversight of the implementation of a Quality Management System (QMS), and ensuring compliance with FDA, ICH, and other regulatory standards. This individual ensures compliance with GxP regulations (GLP, GMP, GCP as applicable) across our CROs. The successful candidate will establish quality frameworks from the ground up and lead quality initiatives that support the company's pipeline from preclinical research through clinical development in a fast-paced, resource-conscious environment. The Associate Director, Quality reports to the Vice President, Head of Regulatory and Quality. This is a full-time hybrid role.

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:

Technical 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

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

Compensation: The salary range for this FTE position is $190, 000 to $220, 000 USD per year. This annual salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location .