Quality Study Representative - US or Canada (Remote)

Requisition Number: 2402

Position Title: Quality Study Representative Quality Assurance Clinical Oversight Program

External Description:

SUMMARY:          The Quality Study Representative (QSR) is responsible for the oversight, delivery, maintenance, reporting, and follow up of assigned QA activities within the Quality Clinical Oversight Program and for ensuring the quality of deliverables within their purview.  

RESPONSIBILITIES:

• Provides consultancy and oversight for project-specific Quality Issues (QIs) and Corrective and Preventive Action (CAPA) Plans
• Maintains up to date electronic filing and management for QI and CAPA related documentation
• Provides consultancy and reviews project-specific Quality Management Documents (QMDs) deviations
• Responsible for QA review of assigned QMDs during revisions or regular review cycles
• Provide GCP consultancy to project teams
• Works collaboratively with the Therapeutic Area Quality Lead (TAQL) to manage the needs of the assigned Therapeutic Area
• May support the oversight and follow-up of CAPA Plan execution for functional and/or corporate QIs
• Performs other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not all-inclusive

OTHER SKILLS AND ABILITIES:

• Communicates professionally, concisely, clearly and consistently to external and internal customers both verbally and in writing
• Customer focused approach to work
• Demonstrates critical thinking skills
• Serves as a positive QA ambassador during all daily activities and customer interactions
• Demonstrates an ability to effectively communicate and influence the outcomes of the decision-making process
• Works with a sense of urgency and recognizes and delivers on time sensitive deliverables
• Works independently, takes initiative and has a flexible approach to work assignments and other assigned tasks
• Adheres to Worldwide Travel Policy

REQUIREMENTS:

• Ability to speak, read and write English fluently
• Working knowledge of ICH Guidelines, FDA regulations, European Directives, and MHRA Statutory Instruments
• Understanding of the Drug Development Process
• IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, SharePoint, and PowerPoint
• College / University degree in nursing, biological, physical, health, pharmacy, or other related science
• 2+ years of relevant GCP, GLP, GVP experience
• Domestic and international travel may be required (not exceeding 10%)

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated based on proven competency, level of responsibility, leadership skills, accountability, and ability to work independently.

 
 #LI-NW1 #IND-NW1 #LI-Remote

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Employment Type: Regular

Community / Marketing Title: Quality Study Representative - US or Canada (Remote)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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