Director, Commercial Quality Assurance
Watertown, MA Quality Assurance
Job Type
Full-time
Description

  

Lyra Therapeutics (Nasdaq: LYRA) is a clinical-stage company pioneering a new therapeutic approach to treat debilitating ear, nose and throat (ENT) diseases that impact the lives of millions of people. Our goal is to transform the ENT treatment paradigm by providing effective front-line solutions for physicians and new treatment options for their patients. In a Phase 1 study, the company observed a rapid, clinically meaningful and durable improvement in symptom score, with 90% of Chronic Rhinosinusitis (CRS) patients having improved symptoms at 24 weeks. A positive Phase 2 study readout of LYR-210 for the treatment of chronic rhinosinusitis with and without nasal polyps was recently announced and LYR-220 is expected in the clinic next year. 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, Commercial Quality Assurance to manage the Quality Assurance operations at the contract sites involved in the production of our combination products for clinical and commercial activities. Reporting to the Vice President, Quality, the Director, Commercial Quality Assurance will be responsible for developing and leading the Quality function supporting the contract manufacturing organizations. 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.


Key Areas of Responsibility:

  • Ensure CMO compliance with all applicable Good Manufacturing Practices including Pre-Approval Inspection Readiness
  • Develop and manage the commercial development quality and compliance strategy encompassing all applicable Good Clinical Practices  and Good Manufacturing Practices
  • Collaborate with CMO to implement a robust quality system that ensures a state inspection readiness, and a culture of Quality
  • Build and maintain a a pharmaceutical based Quality Management System to support late stage clinical and commercial operations
  • Develop and implement a commercial quality strategy and manage those systems and programs to meet corporate goals and objectives
  • Support CMO onsite GMP initiatives and activities
  • Establish CMO product and process quality requirements
  • Evaluate all CMO 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
  • Lead clinical and manufacturing Quality aspects including audits, inspection readiness, design control, manufacturing, lot release, validation, investigations, CAPA, change management, vendor management, document control, and training
Requirements
  • BS or MS in Chemistry, Biology, or a related scientific field with 10+ years of 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 cGMP/international regulations and guidelines 
  • Working knowledge of cGMP, ICH, USP, EU and FDA quality control requirements
  • 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 development
  • Experience with clinical and commercial drug product manufacture including combination drug product validation
  • Strong organizational skills and attention to detail
  • Excellent communication skills including writing, presenting, and negotiating
  • Collaborative team player with excellent communication skills who enjoys working in a highly dynamic, cross-disciplinary environment
  • Ability to travel to CMOs and suppliers as required

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. For consideration, please submit cover letter and CV.