Clinical Quality Assurance Manager
3 hours ago
Lyra Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing innovative, integrated drug and delivery solutions for the localized treatment of patients with chronic diseases. Our mission is to improve patient outcomes and quality of life through cutting-edge research and development.
Job Summary:We are seeking a highly skilled and experienced Manager/Sr. Manager of GCP Clinical Quality Assurance to join our growing Clinical Quality team. The successful candidate will be responsible for overseeing GCP activities across various areas of development, ensuring compliance and quality execution of clinical trials. This role requires a proactive approach to GCP CQA support, independent audits, and effective communication to enhance clinical development practices.
Key Responsibilities:- 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 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 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%).
At Lyra Therapeutics, we value creativity, leadership, and collaboration. We are committed to expanding our platform and seek individuals who are driven to succeed, innovative, and adaptable. If you are a motivated and experienced professional looking for a challenging role, please submit your cover letter and CV for consideration.
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