Director, Clinical Quality Assurance
Job Type
Full-time
Description


Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra's XTreo™ platform is comprised of a biocompatible mesh scaffold, an engineered elastomeric matrix and a versatile polymer-drug complex. The company's current pipeline of therapeutics target tissues deep in the ear, nose and throat passages and are designed to deliver continuous drug therapy for up to six months following a single non-invasive, in-office administration. Lyra's lead product candidate, LYR-210, has initiated a Phase 3 clinical trial for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra's second product candidate, LYR-220, is entering Phase 3 clinical development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management.  Headquartered in the Boston area, Lyra Therapeutics was founded by George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science and biotechnology.


Our team is growing and we are currently seeking an experienced Director, Clinical Quality Assurance to ensure compliance with all applicable Good Clinical Practices (GCP) and Good Laboratory Practices (GLPs) regulations within Lyra and contract organizations.  This position reports to the Vice President, Quality.  The successful candidate will be a team player with experience in a fast-growing combination drug product company, and the ability to successfully collaborate both internally and externally.


Responsibilities

  • Ensure compliance with all applicable GCP and GLP requirements
  • Identify and assess compliance risk areas and implement effective remediation
  • Perform Quality oversight of GCP protocols, ICFs, CSRs, TMFs and other clinical trial specific documents
  • Review, approve and implement clinical SOPs
  • Develop and implement clinical audit plans and schedules
  • Manage the GCP/GLP audit program of routine, non-routine audits of clinical sites, vendors, processes, systems and study documents to ensure data integrity
  • Ensure a state of inspection readiness at Lyra and clinical sites to support successful BIMO and other regulatory inspections
  • Develop and implement a clinical quality strategy and manage those systems and programs to meet corporate goals and objectives
  • Provide management with periodic reports on audit strategies, plans, findings and complaint trends
  • Collaborate with internal and external partners to implement a culture of Quality
  • Build and maintain a phase appropriate Quality Management System to support clinical and non-clinical programs
  • Evaluate all clinical quality events, investigations, complaints, and queries
  • Work actively with all levels and with all disciplines in resolving issues and taking corrective actions
  • Use risk-based logic to ensure appropriate flexibility without compromising compliance
Requirements
  • BS or MS in Chemistry, Biology, or a related scientific field with 10+ years of Clinical Quality Assurance experience, ideally including all phases from clinical through commercial drug product
  • Experienced Quality leader with combination products featuring medical device constituents
  • In depth understanding and application of industry standards and GCP/GLP international regulations and guidelines 
  • Working knowledge of GCP, GLP, ICH, EU and FDA requirements
  • Exceptional organizational skills and attention to detail
  • Excellent communication skills including writing, presenting, and negotiating
  • Ability to lead and provide guidance to multiple projects simultaneously
  • Demonstrated ability to build, develop, and lead a team of quality professionals in support of corporate goals
  • Experience managing/working with third parties and effectively using strong interpersonal skills/diplomacy, and negotiation skills to influence and accomplish work 
  • Familiarity with risk-based approaches suitable for combination product
  • Experience with clinical and commercial drug product manufacture including combination drug product validation
  • Collaborative team player with excellent communication skills who enjoys working in a highly dynamic, cross-disciplinary environment

At Lyra, we value creativity, leadership, and collaboration.  The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable.  We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team.