Clinical QA Specialist/Manager
Omeros is seeking a Clinical QA Specialist/Manager to provide quality and compliance oversight and perform a wide variety of clinical activities ensuring compliance with applicable regulatory requirements.
Good things are happening at Omeros!
Come be a part of our Regulatory Affairs/QA Team!
Who is Omeros?
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system.
Derived from its proprietary PharmacoSurgery® platform, the company’s first drug product, Omidria® (phenylephrine and ketorolac injection) 1%/0.3%, has been approved by the FDA for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission (EC) has approved Omidria® for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has five clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntington’s disease, schizophrenia, and cognitive impairment; addictive and compulsive disorders; and preventing problems associated with urologic surgical procedures. In addition, Omeros has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.
What are your job responsibilities?
In this role you will provide support and proactive strategic planning for QA oversight of clinical development activities. You will be responsible for domestic and international clinical and vendor audits and will work with internal stakeholders, participate cross functionally, and use your creative problem solving skills on complex compliance issues. You’ll conduct audits, facilitate and support regulatory authority GCP inspections, both at clinical sites and at Omeros. Additionally, you’ll develop and/or review CQA SOPs and associated documents.
Your role will include:
- Participating in the evaluation and qualification of CROs and other service providers
- Conducting external and internal audits to assess compliance with GCP requirements, investigational plans, and company standards for clinical trial-related activities
- Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes
- Tracking, reviewing, approving, and assessing the adequacy of CAPAs
- Maintaining databases for audit observations and CAPAs
- Sharing responsibility with the team for the development of training materials and conducting training
- Assisting with the preparation, coordination, and management of regulatory agency inspections
- Reviewing and updating CQA SOPs, identifying the need new CQA SOPs, and developing new CQA SOPs as needed