Clinical Quality Assurance Manager Ora Europe

POSITION TITLE: Clinical Quality Assurance Manager, Ora Europe

DEPARTMENT: Clinical Quality Assurance

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past forty years, our expert teams have helped earn more than fifty new product approvals. Today, our team continues to expand across the globe, with over 350 employees across the US, Europe, Australia, and Asia.

The Role:

The Quality Assurance Manager, Ora Europe will manage the review and improvement of the European quality assurance function. Assists in the development and maintenance of the Company's quality management system (QMS). Report, track, trend Quality Issues (CAPAs, Deviations, Quality Events) as well as European training compliance. Prepare and maintain quality related documentation to include standard operating procedures (SOPs) in support of the QMS. This includes helping to ensure all employees adhere to all standard operating procedures, as applicable to their individual roles. Conduct regular reviews of quality assurance procedures and conduct reviews to assess procedural compliance. Complete regulatory document reviews for study, country and site activation.

What You’ll Do:

As the Quality Assurance Manager, you will manage data and information within Ora's Quality systems and drive compliance with established Quality control processes across the Team.

• Help to develop, maintain, and continuously improve the company's QMS.
• Conduct external vendor audits as needed
• Serve as quality management system European subject matter expert
• Help develop and maintain quality assurance related metrics to help the company understand how it is performing with respect to quality in Europe
• Prepare, revise, and control the company's standard operating procedures (SOPs)
• Regulatory document reviews (Greenlight milestone) and sign off
  • Study level
  • Country level
  • Site level
• Conduct study site audits
• Conduct internal study-related audits / verification of study documentation and QI resolution
• Department level review and oversight of quality compliance and training records
• Collaboration with Clinical Document Quality Specialist (CDQS), Operations and Regulatory to ensure consistent quality standards across the department and studies
• Represent Europe in client meetings, bid defenses, capabilities discussions where there is a QA focus
• Being the primary QA contact and representative for Europe during audits and inspections
• Establish and monitor Quality-related KPIs across the European team
• Quality related training for European team
• Perform other duties as assigned
• Travel requirement of 20%
• Clear and sustained demonstration of Ora’s values - prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
• Responsibilities may differ from the above based on the specific needs of the business.