Clinical QA Manager — GCP & Audit Lead

Omeros Corporation

Seattle (WA)

On-site

USD 135,000 - 195,000

Full time

8 days ago

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Benefits offered by this job

Stock options

Medical, dental, vision benefits

401(k) plan with company match

Paid time off

Job summary

Omeros Corporation in Seattle is seeking a Clinical QA Manager/Sr Manager to provide quality and regulatory oversight for clinical development activities within the Reg QA team. You will lead audits of CROs, coordinate CAPA, and ensure compliance with GCP/ICH across trials, working closely with the clinical team and management.

This role requires travel and offers a competitive compensation package including stock options.

Qualifications

8+ years of experience in GCP/clinical quality assurance.
At least 3 years GCP auditing experience.
In-depth knowledge of GCP, GLP and ICH requirements (ICH E6(R3)).
Strong written and verbal communication, organizational skills, and attention to detail.

Responsibilities

Provide QA oversight of clinical development activities and CRO qualifications.
Conduct and participate in audits to ensure GCP compliance and support CAPA development.
Communicate audit findings and oversee CAPA responses with stakeholders and management.
Review and approve CAPA plans; escalate critical issues as needed.
Draft, review, or revise SOPs to align with GCP requirements and internal standards.
Assist with regulatory inspections preparation and coordination.