- Actively contribute to cross-functional team meetings and provide guidance to GCP functional groups based on interpretation of current regulations to ensure best practices including risk-based management
- Provide proactive GCP QA support for clinical development to ensure patient safety, data integrity, compliance, and operational excellence
- Develop and manage Audit Plans and Audit Reports
- Oversee the audit response process and ensure acceptability of actions addressing findings during the various audits
- Independently conduct audits, including Clinical Investigator Site Audits, GCP Document Audits, internal Process Audits, and support Vendor/System audits
- Draft, review, revise or provide input to GCP/GLP SOPs to assess consistency and compliance with regulatory requirements/internal standards
- Interact and manage contract auditors to help facilitate audit scheduling, conducting pre-audit meetings, drafting and reviewing audit plans, agendas, confirmation letters, peer review audit reports as appropriate
- Work closely with GCP/GLP functional groups to ensure/coordinate appropriate and complete resolution of findings/non-compliances, deviations, investigations, CAPAs in a timely manner, including oversight and approval of all abovementioned activities, as necessary
- Provide QA review of various procedures, clinical protocols, investigators brochure, clinical study reports and pharmacovigilance system management files and other relevant documents as needed
- Escalate issues of critical and major non-compliances and/or lack of urgency in remediation as appropriate
- Drive continuous quality improvement by communicating audit results, CAPAs, and providing GCP guidance to clinical teams
- Support health authority inspection preparation activities and provide oversight during inspections
- Review and contribute to various clinical documentation
- Compile and analyze audit metrics to identify trends for business groups
- Conduct GCP training sessions for business groups
- Work directly with third party vendors and contractors, managing effective chain of communication related to GCP/GLP/GVP compliance
- Bachelor's degree in a related field, advanced degree preferred
- 5+ years of direct GCP pharmaceutical/biotechnology experience in Clinical Quality Assurance auditing
- Experience with using risk-based principles & decision making to ensure ongoing compliance at all stages of product development
- Experience working with all phases of clinical development, especially Phase III
- Solid understanding and application of GCP/GLP guidelines and regulations
- Fundamental knowledge of US, EU, and international regulatory standards and guidelines for clinical trials
- Technical and administrative capabilities to independently conduct routine, complex, and for-cause audits
- A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments
- Experience in inspection management with strong analytical and report writing skills
- Ideal candidate will have broad experience in GCP/GLP environments, regulatory compliance and solid experience in GCP/GLP field auditing
- Ability to represent the CQA Department with professionalism and exceptional interpersonal skills; solid knowledge of negotiation and conflict management skills to assure effective interactions with internal and external stakeholders
- Professional communication skills, strong independent time management, and the ability to manage multiple projects concurrently while dealing with time demands, incomplete information, or unexpected events
- Willingness to travel (approximately 25%)
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Manager/Sr. Manager GCP Clinical Quality Assurance - Waltham, United States - Lyra Therapeutics, Inc.
Description
ApplyDescription
Lyra Therapeutics, Inc.
is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases.
Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities.
LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery.
LYR-210 is designed for surgically naïve patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial.
These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year.
Our Clinical Quality team is growing, and we are currently recruiting for a Manager/Sr. Manager of GCP Clinical Quality Assurance. The Manager will oversee GCP activities across various areas of development, ensuring compliance, and quality execution of clinical trials. They will lead and/or support GCP audits, maintain inspection readiness, and manage key relationships internally and externally. This impactful role requires proactive GCP CQA support, independent audits, and effective communication to enhance clinical development practices.Responsibilities
The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable.
For consideration, please submit cover letter and CV.
