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Sr. Manager, Quality Systems

Company: Omeros Corporation
Location: Seattle
Posted on: July 15, 2019

Job Description:

This position performs a wide variety of activities to ensure compliance with applicable GxP and other regulatory requirements.Good things are happening at Omeros!Come work with our Quality 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?

  • Provide support to the current Quality Systems for GxP activities
  • Ensure that the changes related to manufacturing are evaluated and implemented to meet GMP and internal standards
  • Manage the supplier/vendor qualification systems in support of GMP activities.
  • Manage internal and external Deviation/CAPA system
  • Provide QA support for validations including reviewing protocols and reports
  • Provide support in review of specification and test methods
  • Oversee annual quality management review
  • Ensure compliance with training, doc management, plus preparation and review of Standard Operating Procedures
    • University degree in science and over 7 years of experience in pharmaceutical/ biotech Quality Assurance
      • In-depth knowledge of quality systems and how quality systems are designed and operated to satisfy regulatory requirements
        • Working knowledge and experience with GxP regulations as well as industry standards (USP, Ph. Eur., ICH, FDA, EU guidance
          • Experience in change control, deviation management, and supplier/vendor qualification
            • Knowledge of the principles and practices of computer applications including word processing, spreadsheet, database management, and presentation software and internet search engines
              • Excellent written and verbal skills required
                • Must have the ability to build and maintain positive relationships with management, peers, and subordinates
                  • Must display strong analytical and problem-solving skills
                    • Self-motivated and able to function effectively within team
                      • Attention to detail required
                        • Occasional overnight travel is required
                          • May frequently be performing repetitive movements such as typing on a keypad or using a mouse
                            • May climb, bend, reach, push, pull, balance, stoop, kneel, or crouch
                              • On occasion must lift and/or move up to 25 pounds If you have the skills, knowledge and experience we are seeking, 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 or contact Omeros, asking for Human Resources, at .

Keywords: Omeros Corporation, Seattle , Sr. Manager, Quality Systems, Executive , Seattle, Washington

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