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 contract‑to‑hire position based in Durham, NC. The Manager of Quality Operations will support GxP quality efforts across multiple clinical programs, providing cross‑functional oversight, vendor quality management, and leadership across both GCP and GMP activities.

Responsibilities of the Manager of Quality Operations include:

· Provide GxP quality oversight across clinical and CMC programs, including review of protocols, consent forms, investigational brochures, and related documentation.

· Lead and execute internal and external GxP audit activities, including vendor qualification, audit planning, audit strategy, and review of third‑party audit reports.

· Support quality issue management by assessing site observations, contributing to investigations, and ensuring appropriate corrective and preventative actions.

· Partner with cross‑functional teams and external partners (including CCOs/CDMOs) to represent quality in technical discussions and program leadership meetings.

· Maintain and manage GxP documentation and training activities within Veeva Vault, supporting QMS updates as programs transition into Phase III and beyond.

Qualifications for the Manager of Quality Operations include:

· At least 5 years of hands‑on GCP experience, with additional GMP or broader GxP experience strongly preferred.

· Experience leading program‑level quality oversight activities with demonstrated ownership of quality deliverables or initiatives.

· Strong understanding of CMC and clinical quality requirements, including vendor qualification, method validation review, and tech transfer support.

· Prior exposure to biologics or gene therapy programs, international audit experience, and familiarity with Veeva Vault.

· Bachelor’s degree in a life science or related field, with 8–10 years of biotech/pharma experience preferred for senior‑level consideration.

Compensation for the Manager of Quality Operations:

· Salary Range: $140,000-$150,000/year (USD)

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

This job opens for applications on 2/8/26. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: GCP, GMP, GxP, quality assurance, Veeva Vault, clinical quality, CMC quality, vendor qualification, audit program, biologics, gene therapy, CAPA, clinical development, tech transfer, method validation, global audits, quality oversight, QMS, regulatory compliance, investigator sites, clinical operations, manufacturing quality, risk assessment, cross‑functional leadership, documentation review, SOPs, ICH guidelines, FDA regulations, program management.

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