Manager, Quality

About Sequel 
Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all.
 Sequel’s flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes management. 

Job Overview 

The Manager, Quality will lead key elements of the quality system, ensuring compliance with FDA and EU regulations while driving continuous improvement across Sequel’s Quality Management System (QMS). This role has management responsibility for assigned quality system functions, including ownership of performance, strategic leadership, and oversight of quality initiatives.

This role is currently an individual contributor role but may lead a team as the company grows. The Manager, Quality will partner cross-functionally across the business to diagnose and resolve business challenges, analyzing data to determine appropriate solutions while managing complex projects, and integrate quality processes throughout the organization.

Job Responsibilities and Essential Duties 

• Lead development, implementation, and maintenance of Quality Management System (QMS) elements in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
• Establish, track, and report on key performance indicators (KPIs) and quality metrics to assess and improve QMS performance.
• Drive lifecycle management of quality policies, procedures, and documentation, ensuring compliance and continuous improvement.
• Oversee document and records management for GxP-related documentation, including electronic and paper-based systems.
• Lead efforts to maintain, improve and optimize QMS processes such as change control, training, CAPA, nonconformance, audit, design control, risk management, production/process controls, and supplier management.
• Serve as QMS subject matter expert (SME) and lead/support front room and backroom activities for internal audits, regulatory inspections, and third-party audits.
• Ensure site compliance with good documentation practices (GDP) and cGxP data integrity requirements.
• Partner with cross-functional teams, including Operations, Engineering, Regulatory, and Manufacturing, to integrate quality systems throughout the product lifecycle and ensure ongoing product quality.
• Provide onboarding and training on QMS processes and systems to internal stakeholders.
• Manage and facilitate complex projects related to quality system improvements and compliance initiatives.
• Own/support management review processes, ensuring leadership engagement in quality performance and compliance.
• Champion change management initiatives, ensuring smooth adoption of new processes and system enhancements.

Minimum Requirements 

• Bachelor’s degree in a technical field.
• 5+ years of experience working in a quality function within a medical device, pharmaceutical, or biotech company.
• Experience leading and managing a team of quality professionals preferred.

Required Knowledge, Skills and Abilities 

• Strong expertise in Quality Management Systems (QMS), ISO 13485, FDA 21 CFR Part 820, and risk-based quality principles.
• Proven ability to analyze complex business challenges, develop data-driven solutions, and lead process improvements.