We make injections as easy as pushing a button! Backed by Y Combinator.
About the role
Pirouette is seeking a hands-on Quality Systems & Compliance Lead to help build, maintain, and scale the company’s Quality Management System during a critical stage of product development, partner diligence, and manufacturing readiness.
What they're looking for
- Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Pharmaceutical Sciences, or a related technical discipline
- 7+ years of experience in Quality Assurance, Quality Systems, Compliance, or related functions within the medical device, pharmaceutical, biotechnology, or combination product industries
- Demonstrated experience owning or managing quality system processes in an FDA-regulated environment
- Experience managing internal audits, supporting external audits, and preparing for or supporting regulatory inspections
- Strong working knowledge of FDA Quality System requirements
- Experience with electronic Quality Management Systems, quality record workflows, technical writing, document review, root cause analysis, CAPA, metrics, and quality reporting
More about this role
Pirouette is an innovative, clinical-stage pharmaceutical company focused on developing high-quality, life-improving technologies that meet the highest standards of safety and efficacy. Built around our proprietary OnePush™ delivery platform, we operate a dual-revenue business model: advancing our own high-margin proprietary combination products (via 505(b)(2) and 351(k) pathways) while simultaneously structuring strategic partnerships to place third-party blockbuster drugs into our device. We operate within a robust Quality Management System compliant with ISO 13485, grounded in rigorous design controls, risk management, and regulatory discipline to bring safe and effective products to market.
Pirouette's mission is to make self-care with injectable medications simple, comfortable, and reliable so patients can manage chronic conditions at home with greater confidence and fewer barriers. We are reimagining the delivery of injectable medicines through intuitive design, aiming to establish the first-ever OTC injectable category and execute a massive scale-up of our high-throughput U.S. automated manufacturing.
Pirouette is seeking a hands-on Quality Systems & Compliance Lead to help...
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