Piper Companies · 18 hours ago
Senior Manager of Quality (GCP)
North Carolina, United States
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$70/hr - $85/hr
8+ years expPiper Companies is seeking a Senior Manager of Quality (GCP) to support clinical and CMC activities within the biotech industry. The role is ideal for an experienced Quality professional with strong GCP expertise and broad GxP oversight across global development programs.
Management Consulting
Responsibilities
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
Qualification
Required
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
Strong communication and ability to represent Quality in cross-functional settings
Preferred
5+ years of GCP experience from a sponsor environment preferred
Nice to have: gene therapy, biologics, plasmid/viral vector exposure
Local candidates preferred; remote with limited travel (~10%) acceptable
Benefits
Health
Vision
Dental
PTO
Paid Holiday and Sick Leave if Required by Law
Company
Piper Companies
At Piper, we obsess about the success of our customers and consultants.
501-1000 employees
H1B Sponsorship
Piper Companies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (1)
2023 (2)
2022 (2)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Justin Jordan
Founder and Chairman
Company data provided by crunchbase