Amy Curiel
Senior QA & Product Quality Leader | End-to-End Lifecycle Ownership (API → Distribution) | Risk-Based GMP Decision-Making | Investigations, CAPA, Batch Release | Pharma & Biologics
- Role
- Contract & Consulting Experience Quality Assurance at Multiple Companies
- Location
- Newton, KS, US
- LinkedIn followers
- 500 followers
About Amy Curiel
Senior Quality Assurance and Product Quality leader with extensive experience supporting end-to-end pharmaceutical and biologics product lifecycles, from API and raw materials through manufacturing, final packaging, batch release, and distribution.I bring a risk-based, pragmatic approach to quality, partnering closely with Manufacturing, Technical Operations, and Supply Chain teams to protect product quality while ensuring uninterrupted clinical and commercial supply. My background includes leading complex investigations, CAPA development, batch record review, and product disposition in highly regulated GMP environments.I’ve supported global organizations through both long-term roles and contract/consulting engagements, allowing me to quickly integrate into new teams, adapt to different quality systems, and deliver immediate value with minimal onboarding. I’m known for reducing backlogs, improving cycle times, and helping teams navigate quality events without losing momentum.Core strengths include:• Product Quality Lifecycle Oversight (API → Distribution)• Deviation Investigations & Root Cause Analysis• CAPA Strategy & Effectiveness• Batch Record Review & Batch Release• GMP Compliance & Inspection Readiness• Cross-Functional Leadership & CollaborationI’m open to senior-level Quality Assurance, Product Quality, Quality Operations, and consulting opportunities, with a preference for remote or hybrid roles and limited travel as needed.I’m known for making sound, risk-based quality decisions and work best in environments where quality is a collaborative partner, balancing compliance, patient safety, and business needs.
Experience
Contract & Consulting Experience Quality Assurance
Jan 2025 — Present · US
Clients: Indivior, Novartis, AGC Biologics• Serve as Quality lead providing senior-level oversight across the entire product lifecycle, from API and raw materials through manufacturing, packaging, batch release, and downstream distribution.• Lead and support complex deviation investigations, root cause analysis, and CAPA development in cGMP environments.• Review and approve batch records, technical reports, and quality documentation to support timely product release.• Partner with Manufacturing, Supply Chain, and Technical Operations teams to resolve quality events without impacting supply.• Rapidly onboard to client quality systems (e.g, TrackWise, Veeva Vault) and deliver immediate value with minimal training.• Consistently support timely product disposition and supply continuity while maintaining full cGMP compliance.
Education
Wichita State University
Biology, General
2004 — 2008
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