Manager/Sr. Manager, Clinical QA

About the role

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.

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.

Qualifications

• 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%.

Behavioral Competencies

• 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.

Pay

• Clinical QA Mgr: $135,000 – $160,000
• Clinical QA Sr Manager: $150,000 - $195,000
• Salaries will be determined based on knowledge, skills, education, and experience relevant to the role.

Benefits

• Medical, dental, vision, and life insurance
• 401(k) plan with a company match
• Three weeks of vacation and 80 hours of sick time accrued annually
• Twelve paid holidays throughout the calendar year
• Eligible for incentive and stock options