<p>Job Title: Associate Director, Quality</p> <p>Location: Hybrid</p> <p>Reports to: Vice President, Head of Regulatory</p> <p>Full/Part-Time: Full-Time</p> <p>Regular/Temporary: Temporary 6 months, with possibility of 6-month extension</p> <p>Job Summary</p> <p>The Associate Director of Quality is responsible for leading and managing quality assurance activities by providing strategic oversight of Contract Research Organizations (CROs) to support implementation of a Quality Management System (QMS), ensuring compliance with FDA, ICH, and other regulatory standards. This individual ensures compliance with GxP regulations (GLP, GMP, GCP as applicable) and collaborates closely with cross-functional teams to ensure product development, testing, and manufacturing meet regulatory standards and company quality expectations. 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.</p> <p>What You Will Do:</p> <p>Quality Program Development & Leadership</p> <ul> <li>Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, ICH, FDA, EMA, etc.) </li><li>Lead quality risk assessments with a focus on resource optimization and critical path activities </li><li>Implement pragmatic quality approaches that balance compliance with operational efficiency </li><li>Create quality culture and awareness across all organizational levels </li><li>Excellent leadership, communication, and interpersonal skills </li></ul> <p>CRO Management & Strategic Partnerships</p> <ul> <li>Serve as the primary quality liaison for CDMO partnerships, overseeing quality agreements, audits, and ongoing compliance activities. </li><li>Implement risk-based CRO oversight programs optimized for resource efficiency </li><li>Build strong working relationships with CRO quality teams to ensure seamless collaboration </li><li>Manage CRO performance with emphasis on speed, quality, and value delivery </li></ul> <p>Quality Systems & Documentation</p> <ul> <li>Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, ICH, FDA, EMA, etc.). </li><li>Ensure proper documentation and record-keeping practices </li><li>Lead development of standard operating procedures (SOPs) and work instructions </li><li>Maintain document control and change management processes </li><li>Review and approve key quality documentation, including protocols, reports, SOPs, batch records, and laboratory data. </li></ul> <p>Technical Requirements and Skills:</p> <p>Technical Skills</p> <ul> <li>Deep understanding of FDA, ICH, and international regulatory requirements </li><li>Extensive knowledge of GMP, GLP, and GCP principles </li><li>Experience with quality management systems and quality metrics </li><li>Strong understanding of pharmaceutical development processes </li><li>Proficiency in risk management methodologies (ICH Q9, Q10) </li><li>Experience with quality auditing and inspection processes </li></ul> <p>Qualifications</p> <ul> <li>Bachelor's degree in life sciences or related field required </li><li>8 + years of pharmaceutical/biotech industry experience </li><li>Previous startup or small company experience highly preferred </li><li>Experience building quality programs and processes from early stages </li><li>Minimum 3-5 years of experience managing CROs and vendor relationships </li><li>Experience with novel therapeutic modalities (biologics, cell/gene therapy, etc.) </li><li>Excellent leadership, communication, and interpersonal skills. </li></ul> <p>Compensation: The salary range for this temporary position is $80.00 to $93.00 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.</p>