Manager, Clinical QA

We are a fast-growing and dynamic organization seeking a Clinical QA Manager/Sr Manager to join our Reg QA team.  This position provides quality and compliance oversight and performs a wide variety of QA activities to ensure clinical trials in compliance with applicable regulatory requirements.

Good things are happening at Omeros!

Who is Omeros?

Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead complement inhibitor YARTEMLEA (narsoplimab-wuug), which targets the lectin pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older.

OMS
1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.

Under a recently announced asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS
906), an inhibitor of MASP-3, the alternative pathway’s key activator, which is in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS
527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. For more information about Omeros and its programs, visit .What are your job responsibilities? Provide support and proactive, strategic planning for QA oversight of clinical development activities.

Participate in the evaluation and qualification of 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 for clinical trial-related activities. Communicate audit findings to audit stakeholders to ensure understanding and oversee the audit response process to develop Corrective and Preventive Action Plans (CAPAs) to address root causes.

Work closely with clinical team to ensure/coordinate appropriate and complete resolution of non-compliant issues, quality investigations, etc. in a timely manner, including review and/or approval of CAPA plans, as necessary. As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to management team.

Perform root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management.

Maintain the highest level of awareness, expertise in GCP regulations and internal policies and SOPs.Provide guidance to clinical team based on interpretation of current regulations to ensure best practices including risk-based management

Draft, review, or revise SOPs to assess consistency and compliance with GCP regulatory requirements/internal standards.

Share responsibility with the team for the development of training materials and conduct training. Assist with preparation of, coordination, and management of regulatory agency inspections.

What education and experience do you need?

University degree in science and minimum of 8 years of experience in GCP/clinical quality assurance. At least 3 years GCP auditing experience

In-depth knowledge and experience with GCP, GLP and ICH requirements, especially ICH…