Lumicell

Senior Director of Quality

Lumicell

full-time

Posted on:

Location Type: Hybrid

Location: Waltham • Massachusetts • United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Overseeing the comprehensive quality, compliance, regulatory strategy, and operational excellence of Lumicell's drug/device combination product
  • Directing the integration of quality management systems, supplier quality, quality engineering, and working with regulatory affairs to ensure products meet all customer and regulatory standards from concept through post-launch
  • Maintaining and continuously improving a scalable Quality Management System (QMS) to ensure alignment with QMSR, cGMP, 21 CFR Parts 210, 211, and 820, and ISO 13485 across all functional groups supporting FDA-regulated medical devices and drugs
  • Developing and implementing quality systems and SOPs for device and drug quality management, ensuring alignment with cGMP and other regulatory standards
  • Overseeing all Quality Engineering functions, ensuring that devices and drugs are designed and manufactured in compliance with applicable FDA regulations and ISO standards (ISO 13485, ISO 14971)
  • Acting as a subject matter expert in design quality and risk management; leading the company's Management Review process
  • Developing and managing quality metrics and quality objectives to monitor performance, inform management decisions, support continuous improvement initiatives, and assist in preparation of regulatory submissions for product approvals
  • Leading supplier quality management for devices and drugs, managing the entire process from selection and onboarding to ongoing performance evaluations of contract manufacturers (CMOs) and other suppliers
  • Directing design control activities, managing robust process validation, risk management, and ensuring compliance from concept through post-launch per 21 CFR 820.30
  • Owning and managing the risk management program in accordance with ISO 14971, including hazard analysis and risk/benefit assessments across the product lifecycle
  • Leading the company through FDA inspections, including serving as the primary host and spokesperson during on-site visits
  • Managing all aspects of inspection, including corporate readiness, real-time coordination during the audit, preparation of Form 483 responses, and development and execution of corrective action plans submitted to regulatory agencies
  • Leading and managing post-market surveillance, including device investigations for complaints and field actions, and MDR reporting
  • Supporting post-market pharmacovigilance programs for the drug component, ensuring timely adverse event reporting and signal detection in compliance with 21 CFR Part 314, part 3 and applicable post-approval requirements
  • Supporting all quality aspects of Clinical Affairs programs in compliance with 21 CFR 312, 21 CFR 812, and ISO 14155:2020

Requirements

  • Bachelor's degree required in scientific, engineering or regulatory discipline (e.g., Biology, Chemistry, Biomedical Engineering, or related field); Master’s degree preferred
  • Certification as a CQE, CRE, Manager of Quality, and/or Six Sigma Black Belt
  • Minimum 10+ years of progressive experience in quality assurance within the medical device, with significant leadership experience including managing supplier quality and quality assurance teams across devices and drugs; experience with pharmaceutical and device/drug regulatory affairs is a plus
  • Minimum 5 years in a director-level or senior leadership role with demonstrated people management responsibilities and scaling the QA/RA organization
  • Hands-on experience with combination product regulatory frameworks (21 CFR Parts 3 & 4)
  • Demonstrated track record of successful FDA submissions; IND/NDA, IDE/510(k)/PMA experience required
  • Comprehensive knowledge of FDA and international regulatory standards applicable to medical devices and pharmaceuticals, including 21 CFR Parts 820 and 210/211, ISO standards, and ICH guidelines
  • Demonstrated experience leading a company through FDA inspections (e.g., Pre- and Post-approval Inspections, Supplier Inspections, GMP/GCP audits); must have personally served as the primary host or lead during at least one formal regulatory inspection
  • Proven track record of successfully managing FDA Form 483 observations and Warning Letter responses, including the development and implementation of robust corrective and preventive action (CAPA) plans
  • Experience designing and executing inspection readiness programs, including mock audits, gap assessments, and staff training across manufacturing, clinical, and laboratory environments
  • Proven track record in managing quality systems, strongly preferred in an early-stage/start-up environment, and leading comprehensive quality functions
  • Experience with electronic QMS (eQMS) platforms, preferably Arena
  • Familiarity with post-market pharmacovigilance programs for drugs and complaints management for devices, including MDR reporting
  • Strong leadership skills with the ability to mentor and develop teams
  • Excellent problem-solving, organizational, and written and verbal communication skills.
Benefits
  • Lumicell is committed to a diverse and inclusive workplace
  • Reasonable accommodations for qualified individuals with known disabilities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality management systemsquality engineeringregulatory compliancerisk managementdesign controlprocess validationquality metricsadverse event reportingpost-market surveillanceSOP development
Soft Skills
leadershipproblem-solvingorganizational skillscommunication skillsmentoringteam developmentcontinuous improvementstrategic thinkingcollaborationdecision-making
Certifications
CQECREManager of QualitySix Sigma Black Belt