Senior Manager of Quality (GCP)

Piper Companies is seeking a Senior Manager of Quality (GCP) to support clinical and CMC activities within the biotech industry. The Senior Manager of Quality (GCP) role is ideal for an experienced Quality professional with strong GCP expertise and broad GxP oversight across global development programs. The Senior Manager of Quality (GCP) is a contract to hire opportunity and prefers candidates that are local to the Durham, NC area (open to remote for the right candidate).

Responsibilities of the Senior Manager of Quality (GCP):

• Oversee quality for Phase 1–3 clinical programs, including global regions.
• Review clinical protocols, IBs, ICFs, and study materials.
• Review CMC documentation, including DS/DP/plasmids, batch records, labels, and validation files.
• Manage vendor qualification and ongoing compliance.
• Support and review clinical site audits; perform audits as needed.
• Participate in technical meetings and provide Quality guidance.
• Support updates to SOPs and QMS as programs advance.
• Partner with cross‑functional teams in Clinical, CMC, and Quality.

Requirements of the Senior Manager of Quality (GCP):

• •8–10+ years of Quality Assurance experience.
• 5+ years of GCP experience from a sponsor environment preferred.
• Experience supporting both clinical and CMC quality.
• Background reviewing protocols, CMC docs, and validation/qualification materials.
• Experience conducting or supporting clinical site audits.
• Nice to have: gene therapy, biologics, plasmid/viral vector exposure.
• Strong communication and ability to represent Quality in cross-functional settings.
• Local candidates preferred; remote with limited travel (~10%) acceptable.

Compensation for the Senior Manager of Quality (GCP):

• Salary range: $70.00 - $85.00/ hour, depending on experience
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.

Keywords: senior manager quality, GCP, GxP, clinical quality, CMC, biotechnology, plasmids, gene therapy, audit program, clinical site audits, batch record review, vendor qualification, global trials, method validation, QA compliance, clinical development quality, CMC oversight

This job opens for applications on 1/27/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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