Manager, Clinical QA

Omeros•Seattle, WA

6d•$135,000 - $195,000

About The Position

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. OMS1029, 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 OMS906), 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 OMS527, 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 www.omeros.com.

Requirements

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 E6(R3).
Expert organizational, written and verbal communication skills with the ability to present in a professional manner are required.
Proven attention to detail and organizational skills are essential.
Strong computer skills required in applications used in general office settings including word processing, spreadsheet, database management, presentation software, and Internet search engines.
Excellent oral and written communication skills, including the ability to write routine reports and correspondence and influence internal and external colleagues and collaborators in a positive manner.
Strong interpersonal skills and the ability to represent Omeros in a professional manner are essential, as are demonstrated ability to exercise discretion.
Requires the ability to both work as a collaborative team member and independently.
Strong decision-making, situation analysis, and creative problem-solving skills are required.
Must have ability to organize, plan and prioritize multiple tasks to meet deadlines, while strategically thinking ahead and escalating issues as appropriate.
The employee is required to travel 25 - 35%.
Must have the ability to build and maintain positive relationships with management, peers, and subordinates.
Excellent written and verbal skills required.
Must display strong analytical and problem-solving skills.
Attention to detail required

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.