Senior Manager, Quality

About Sequel 
Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices. 

Job Overview 

The Senior Manager, Quality will lead the Quality Systems function, ensuring compliance with FDA and EU regulations while driving continuous improvement across Sequel’s Quality Management System (QMS). This role has full management responsibility for the quality systems function, including ownership of QMS 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 Senior 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 the development, implementation, and maintenance of a comprehensive Quality Management System (QMS) 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 improve and optimize change control, training, CAPA, nonconformance, audit, and risk management processes. 

• Serve as QMS subject matter expert (SME) and primary liaison 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. 

• Provide end-user 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 and oversee 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 or equivalent experience. 

• 7+ 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. 

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. 

• Strong project management and leadership skills, with the ability to manage moderate-risk, complex projects. 

• Self-starter, independently drives projects to completion. 

• Previous experience in a startup environment, or ability to work through ambiguity and pivot quickly when priorities change. 

• Excellent communication and interpersonal skills, with the ability to influence and drive quality initiatives across functions. 

• Ability to work as a change agent, facilitator, mentor, and coach within a fast-paced, growing organization. 

• Quality certifications a plus: ASQ, CQE, CQM. 

• Ability to travel nationwide and internationally, up to 10%. 

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

At Sequel, we believe that when you thrive, we thrive. That’s why we’ve designed a benefits package that’s as thoughtful as it is generous. From day one, you’re automat