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.