Associate Director of Quality Operations

We are seeking an experienced Associate Director of Quality Operations to support and strengthen a rapidly growing pre‑clinical and clinical gene therapy programs. The ideal candidate will bring deep GXP Quality Assurance experience across clinical, CMC, and non‑clinical functions, along with a proven ability to build, implement, and maintain Quality Management Systems. This individual must be highly organized, proactive, and ready to drive quality excellence as the company advances its pipeline and prepares for future regulatory inspections. This role is hybrid with about 1-2 days on-site per week in the Durham, North Carolina.

Responsibilities of the Associate Director of Quality Operations:

• Provide GXP QA oversight across Clinical, CMC, and Non‑Clinical teams, including development of risk assessments, quality plans, quality agreements, and participation in QA‑QA forums.
• Collaborate with external vendors and internal stakeholders to ensure quality expectations are met and project objectives are delivered in a compliant and timely manner.
• Assess compliance of vendors, investigator sites, and study activities with protocols, SOPs, ICH guidelines, and all applicable regulatory requirements.
• Develop and implement the internal/external GXP audit program, including scheduling, consultant oversight, and audit report review and approval.
• Lead the Significant Quality Issues management process, including root‑cause assessments and corrective and preventive action (CAPA) development.
• Ensure timely and appropriate escalation of quality issues, including potential misconduct or significant deviations, to Leadership.
• Oversee GXP document management and training initiatives using the Veeva Vault QualityDocs platform.
• Drive a strong Quality Culture, championing Data Integrity and Good Documentation Practices (GDP).
• Lead GXP PAI readiness activities in partnership with Quality and functional leaders.
• Establish and track GXP quality metrics and contribute to Quality Management Reviews and Quality Council processes.

Qualifications of the Associate Director of Quality Operations:

• Bachelor’s degree required, preferably in Life Sciences; advanced degree a plus.
• Minimum 10 years of biotech/pharmaceutical industry experience, ideally with biologics or gene therapy exposure.
• Strong GXP Quality Assurance background with experience across clinical research, GCP, with GMP experience as a plus.
• Experience designing, implementing, and maintaining Quality Management Systems.
• Experience with Veeva Vault is a plus.
• Knowledge of FDA regulations, ICH guidelines, and global GXP requirements.
• CQA certification preferred.
• Ability to independently manage multiple complex projects in a fast‑paced environment.
• Self‑motivated, detail‑oriented, and highly organized with excellent communication skills.
• Ability to work collaboratively in cross‑functional teams as well as independently with minimal supervision.
• Hands‑on, solutions‑oriented approach with strong problem‑solving skills.
• Ability to work effectively with internal teams, external vendors, and stakeholders at all organizational levels.

Compensation for the Senior Manager, Quality Operations:

• Pay Range: $170,000-$175,000, plus 10% bonus
• Benefits: Comprehensive benefits including Health, Dental, Vision, PTO, and sick leave as required by law

Keywords:

quality operations, GXP, QA, quality assurance, gene therapy, biologics, pre‑clinical, clinical development, GCP, GMP, GLP, QMS, Veeva Vault, ICH, regulatory compliance, CAPA, audit program, PAI readiness, data integrity, quality oversight, biotech, pharmaceutical, quality culture

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Applications for this posting will be accepted for at least 30 days after the date posted (2/15).