Manager of Quality Operations

Piper Companies is seeking a Manager of Quality Operations to join an innovative organization in the biotech and gene therapy industry for a permanent position in Durham, NC. The Manager of Quality Operations will support GXP quality efforts across pre‑clinical and clinical programs, providing quality oversight, documentation management, and vendor compliance leadership.

Responsibilities of the Manager of Quality Operations include:

· Provide GXP QA oversight to cross‑functional clinical, CMC, and non‑clinical teams while partnering with external vendors and investigator sites.

· Lead development and implementation of risk assessments, quality plans, quality agreements, and related quality oversight initiatives.

· Manage the internal/external GXP audit program, including scheduling, consultant oversight, and audit report review and approval.

· Oversee Significant Quality Issues, including root cause assessment and corrective and preventative action planning with timely escalation to leadership.

· Maintain GXP documentation and training programs within the Veeva Vault QualityDocs platform.

Qualifications for the Manager of Quality Operations include:

· Bachelor’s degree required, preferably in life sciences, with at least ten years of biotech/pharma experience including biologics or gene therapy.

· Strong background in GXP quality assurance across GCP, GMP, pre‑clinical and clinical development, and quality management systems.

· Experience designing, implementing, and managing Quality Management Systems, with Veeva Vault experience preferred.

· Knowledge of FDA regulations, ICH standards, and global regulatory requirements with demonstrated capability in vendor oversight and compliance assessment.

· Excellent communication skills, strong organizational abilities, and proven success managing multiple projects in dynamic environments.

Compensation for the Associate Director, Quality Operations:

· Salary Range: $140,000-$160,000/year (USD)

· Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 01/23/26. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: GXP, QA, quality assurance, Veeva Vault, QualityDocs, clinical development, CMC, non‑clinical, gene therapy, AAV, quality management system, QMS, audit program, clinical trial quality, data integrity, good documentation practices, GCP, GMP, FDA regulations, ICH, vendor oversight, root cause analysis, CAPA, compliance, biologics, biotechnology, regulatory requirements, inspection readiness, PAI readiness, quality metrics, document management, training management, clinical operations.

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