Manager/Sr. Manager, Clinical QA
Omeros Corporation
August 25, 2026
Remote friendly (Seattle, WA)
United States
$135,000 - $195,000 USD yearly
Clinical Research and Development
Responsibilities:
- Provide support and proactive, strategic planning for QA oversight of clinical development activities.
- Evaluate and qualify CROs and other service providers.
- Conduct and/or assist in external and internal audits to assess compliance with GCP requirements, investigational plans, and company standards.
- Communicate audit findings, oversee audit response, and develop CAPAs to address root causes.
- Coordinate timely resolution of non-compliant issues/quality investigations; review/approve CAPA plans as needed; escalate critical non-compliance and remediation urgency gaps.
- Perform root cause analysis and provide QA metrics for tracking/trending to functional and senior management.
- Maintain expertise in GCP regulations, internal policies, and SOPs; provide guidance to clinical teams (including risk-based management).
- Draft, review, or revise SOPs for consistency and GCP compliance.
- Develop training materials and conduct training.
- Assist with preparation, coordination, and management of regulatory agency inspections.
Qualifications/Requirements:
- Science degree; minimum 8 years’ experience in GCP/clinical quality assurance.
- At least 3 years GCP auditing experience.
- In-depth knowledge of GCP, GLP, and ICH requirements, especially ICH E6(R3).
- Strong organizational skills; expert written/verbal communication.
- Strong computer skills (word processing, spreadsheets, databases, presentations, internet).
- Ability to work independently and collaboratively; strong analytical/problem-solving skills; decision-making and prioritization.
- Travel 25–35%.
Benefits:
- Medical, dental, vision, life insurance, and 401(k) with company match; 3 weeks vacation, 80 hours sick time annually, 12 paid holidays; eligible for incentive and stock options.
Compensation (range):
- Clinical QA Manager: $135,000–$160,000; Clinical QA Sr. Manager: $150,000–$195,000.
- Provide support and proactive, strategic planning for QA oversight of clinical development activities.
- Evaluate and qualify CROs and other service providers.
- Conduct and/or assist in external and internal audits to assess compliance with GCP requirements, investigational plans, and company standards.
- Communicate audit findings, oversee audit response, and develop CAPAs to address root causes.
- Coordinate timely resolution of non-compliant issues/quality investigations; review/approve CAPA plans as needed; escalate critical non-compliance and remediation urgency gaps.
- Perform root cause analysis and provide QA metrics for tracking/trending to functional and senior management.
- Maintain expertise in GCP regulations, internal policies, and SOPs; provide guidance to clinical teams (including risk-based management).
- Draft, review, or revise SOPs for consistency and GCP compliance.
- Develop training materials and conduct training.
- Assist with preparation, coordination, and management of regulatory agency inspections.
Qualifications/Requirements:
- Science degree; minimum 8 years’ experience in GCP/clinical quality assurance.
- At least 3 years GCP auditing experience.
- In-depth knowledge of GCP, GLP, and ICH requirements, especially ICH E6(R3).
- Strong organizational skills; expert written/verbal communication.
- Strong computer skills (word processing, spreadsheets, databases, presentations, internet).
- Ability to work independently and collaboratively; strong analytical/problem-solving skills; decision-making and prioritization.
- Travel 25–35%.
Benefits:
- Medical, dental, vision, life insurance, and 401(k) with company match; 3 weeks vacation, 80 hours sick time annually, 12 paid holidays; eligible for incentive and stock options.
Compensation (range):
- Clinical QA Manager: $135,000–$160,000; Clinical QA Sr. Manager: $150,000–$195,000.