Associate Director, Clinical QA

Location
Seattle
Posted
Nov 07, 2020
Ref
1785
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Omeros is seeking an Associate Director, Clinical QA 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 Clinical 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 CRO's 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 for 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 8+ years of relevant pharmaceutical industry experience in GCP/clinical quality assurance with a minimum of 5 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
  • 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!

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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.