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.

• 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 Quality Docs platform.

• 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.

• 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.