Job Title : Associate Director, Quality Location : Hybrid Reports to : Vice President, Head of Regulatory and Quality Full/Part-Time : Full-Time Regular/Temporary : Temporary 6 months, with possibility of 6-month extension Job Summary 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.

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. ). 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

and Skills: Technical Skills Deep understanding of FDA, EMA, & ICH regulatory

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

00 USD per hour. This 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 .