СШАQuality Systems & Compliance Lead
1 нед. назад
90k–130k USD / годСШАLead
quality management systemiso 13485risk managementdesign controlsregulatory complianceaudit management
Lead the Quality Systems & Compliance to build and scale the Quality Management System in a pharmaceutical company.
Требования
- 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.
- Strong communication, organization, and cross-functional leadership skills, with the ability to influence without direct authority and drive actions to closure.
- Highly self-directed, detail-oriented, accountable, and comfortable operating with urgency and ambiguity in a fast-paced environment.
Будет плюсом
- Experience working in a startup, early-stage, clinical-stage, or rapidly scaling organization.
- Experience supporting combination product development, manufacturing readiness, regulatory submissions, partner diligence, or commercial scale-up.
- Demonstrated ability to build practical, scalable quality systems that support innovation, compliance, inspection readiness, and patient safety.
Условия
- Occasional domestic and international travel may be required to support audits, suppliers, manufacturing partners, and inspection activities.
- Some off-hours support may be required during audits, inspections, regulatory submissions, or critical development and manufacturing activities.
- This role requires a high level of responsiveness when urgent quality, compliance, audit, inspection, or development-program needs arise.
- Competitive compensation and equity participation
- Comprehensive benefits, including health, dental, vision, basic life and AD&D insurance, and 401(k) matching
- Discretionary paid time off
- A collaborative, mission-driven environment with the opportunity to make a meaningful impact
- The opportunity to help build and scale a world-class combination product Quality Management System
- Portsmouth, NH
- 100% Onsite
Другое
- 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 build, maintain, and scale the company’s Quality Management System during a critical stage of product development, partner diligence, and manufacturing readiness. Reporting to the Vice President of Quality, this role will own assigned QMS elements, manage audits and inspections, support 21 CFR Part 4 compliance, and provide practical quality systems leadership across development, manufacturing, regulatory, supply chain, and external partner activities.
- The ideal candidate is a detail-oriented quality professional with strong working knowledge of medical device, pharmaceutical, and/or combination product requirements who can translate regulatory expectations into phase-appropriate, executable processes. This is a high-impact role for someone who thrives in a fast-paced startup environment, operates independently, drives follow-through, and wants to help build a scalable quality system that supports clinical development and future commercial readiness.
- This is a full-time, onsite position based in Portsmouth, New Hampshire.
- Own assigned QMS processes, including procedure maintenance, implementation support, monitoring, metrics, and continuous improvement.
- Serve as process owner or deputy owner for areas such as document control, training, change control, CAPA, nonconformances, complaints, audits, management review, and quality metrics.
- Ensure QMS procedures, records, and practices remain aligned with FDA requirements, ISO 13485, company policies, and phase-appropriate business needs.
- Support electronic quality systems, workflows, dashboards, and scalable quality processes for clinical development, manufacturing readiness, partner diligence, and future commercial operations.
- Manage the internal audit program, including planning, execution, reporting, finding management, corrective action follow-up, and effectiveness verification.
- Coordinate and support external audits involving suppliers, contract manufacturers, CDMOs, sterilization providers, testing laboratories, consultants, and service providers.
- Serve as a quality representative during customer, partner, certification body, and regulatory audits or inspections.
- Maintain inspection readiness by ensuring audit evidence, QMS records, quality metrics, responses, commitments, and remediation actions are organized, current, and tracked through closure.
- Partner with the VP of Quality to establish, maintain, and improve Pirouette’s combination product quality framework.
- Drive awareness and execution of 21 CFR Part 4 requirements across applicable device, drug, development, manufacturing, supplier, and quality system activities.
- Support integration of design controls, risk management, purchasing controls, CAPA, production controls, complaint handling, and documentation practices into the combination product quality system.
- Assess process gaps and support regulatory submissions, partner due diligence, and sponsor/customer requests with practical QMS documentation and compliance evidence.
- Prepare quality metrics, dashboards, trends, and status reports for the VP of Quality and leadership team.
- Support Management Review preparation, including audit outcomes, CAPA trends, supplier quality status, complaint trends, compliance risks, and improvement actions.
- Identify compliance risks, process gaps, documentation issues, and opportunities to improve QMS efficiency and effectiveness.
- Lead or support cross-functional quality improvement initiatives that strengthen accountability, inspection readiness, operational discipline, and patient safety.