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 commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.
The company’s drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. 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 has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
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
What experience and education do you need?
You’ll need a Bachelor’s degree in a life science or a related field with 5+ years of relevant pharmaceutical industry experience in GCP/clinical quality assurance with a minimum of 2 years of Good Clinical Practices (GCP) auditing experience. Global Clinical QA experience is desired.
What skills does our ideal candidate have?
As our ideal candidate, your areas of expertise include Phase 1 – Phase 4 clinical trials, clinical investigator site audits, vendor audits, and ICH/GCP knowledge. In addition, you’ll possess:
An in-depth knowledge and clear understanding of GCP regulations and industry standards
Excellent organizational, planning, and prioritizing skills
Exceptional communication skills, both written and verbal
Effective cross-functional and intra-functional collaboration skills
Demonstrated success in building and maintaining relationships as well as influencing internal and external colleagues and collaborators
The ability to present in a professional manner and write routine reports and correspondence
Strong computer skills in applications used in general office settings such as word processing, spreadsheet, presentation, data base management, and internet search engine applications.
Strong decision-making, situation analysis, and creative problem-solving skills.
A proven attention to detail and an orientation for meticulous work
Other Things You’ll Need To Know:
This role requires 20% to 30% travel, both domestic and international
If you have the skills, knowledge and experience we are looking for and would like to join a growing and exciting organization where you will have the opportunity to play an integral role, we’d love to hear from you!
All interested applicants should apply at: Omeros.com, About Omeros, Careers. This will route you to our online applicant tracking system.
Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.
It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000.
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing both 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.