Quality Systems & Compliance Lead
Portsmouth, NH$90k - $130kFull-timePosted 4w ago
About the role
Hands-on Quality Systems & Compliance Lead to build, maintain, and scale Pirouette’s Quality Management System for clinical development, manufacturing readiness, and partner diligence in a fast-paced startup. Reports to VP of Quality; onsite in Portsmouth, NH.
Responsibilities
- 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.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Pharmaceutical Sciences, or related technical discipline.
- 7+ years of experience in Quality Assurance, Quality Systems, Compliance, or related functions within 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.
Skills
Required:Quality Management System (QMS) ownershipAudits & inspections management21 CFR Part 4 compliance
Nice to have:Regulatory submissions support
Benefits
- 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
- Collaborative, mission-driven environment with the opportunity to make a meaningful impact
- Opportunity to build and scale a world-class combination product Quality Management System
Last updated Sep 23, 2026. Interested? Apply on the company site.
About Pirouette Pharma
We make injections as easy as pushing a button!
At Pirouette, we have developed a low-profile, disk-shaped, rugged injection device with a patient-centric focus on affordability, portability, and usability. The patented device, based on extensive patient input, is designed to make administering an injection as easy as pushing a button. This allows individuals with limited or no training to easily and intuitively perform an injection on themselves or others.
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