Associate Director, GXP Quality Systems

BLOSSOMHILL THERAPEUTICS INC • San Diego, CA

9d

About The Position

The Associate Director, GxP Quality Systems is responsible for the development, implementation, and ongoing management of the company’s Quality Management System (QMS) supporting GxP activities. This role ensures that quality processes and systems effectively support compliant operations across clinical, regulatory, and operational functions.

Requirements

• Bachelor’s degree in a scientific discipline or related field.
• 6+ years of progressive experience in Quality Assurance or Quality Systems within the pharmaceutical or biotechnology industry.
• Experience supporting clinical development programs and familiarity with GMP and/or GCP regulations and guidelines.
• Experience working with electronic Quality Management Systems (e.g., Veeva, TrackWise, or similar platforms).
• Strong organizational, analytical, and problem-solving skills.
• Excellent written and verbal communication skills.

Nice To Haves

• Experience working in a virtual or outsourced development environment is preferred.

Responsibilities

• Develop, implement, and maintain the company’s GxP Quality Management System supporting clinical development and broader GxP activities.
• Provide governance for core quality processes including document management, training administration, and quality event processes (e.g., deviations, change control, and CAPA).
• Ensure quality policies, procedures, and standards support compliance with applicable GXP regulations, guidelines, and other relevant regulatory requirements.
• Maintain oversight of electronic quality management systems (eQMS), including administration, configuration, and alignment with company quality processes.
• Partner with functional Quality leads to ensure quality processes are implemented consistently across GxP activities.
• Monitor the effectiveness of quality processes and drive continuous improvement initiatives within the QMS.
• Develop and maintain quality metrics and dashboards to evaluate compliance trends and system performance.
• Prepare quality system reports and compliance summaries for review by senior management.
• Provide guidance and training to internal teams on quality system processes and expectations.
• Collaborate with clinical operations, regulatory, CMC, and other functional teams to support implementation of quality processes.
• Represent Quality Systems on cross-functional initiatives related to quality process development or improvement.
• Collaborate with the GMP and GCP Quality functions to support quality oversight of manufacturing and clinical development activities.
• Support the development and maintenance of clinical quality procedures and standards.
• Assist with inspection readiness activities related to manufacturing, clinical trials and regulatory inspections.
• Contribute to quality initiatives that strengthen compliance across clinical programs and GXP vendors.
• Support internal and external audit programs, including preparation, coordination, and follow-up activities.
• Participate in vendor qualification and oversight activities where quality system processes are involved.
• Contribute to broader GxP Quality initiatives across the organization.

What This Job Offers

• Job Type: Full-time
• Career Level: Director