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오늘 LA공항 북쪽의 Playa Vista에서 위치한 healthcare회사에서 IT Computer QA Manager 요청이 왔습니다.
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Resume to : info@a2zreturnvalues.com

Senior Manager, Computer Quality Assurance

Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients’ homes. By leveraging the latest innovations in mobile technology, cloud services, telemedicine, and mass-engagement channels like Facebook and Google, we are breaking down traditional geographic barriers to patient trial participation while shortening the time needed to bring new treatments to market.

We value employee well-being and aim to provide team members with everything they need to succeed. Enjoy daily healthy catered lunches, snacks and beverages, and top-notch equipment such as the latest Macbook Pro, 4k monitors, and adjustable standing desks.

Position Overview

The Senior Manager, Computer QA will provide daily, quality assurance oversight of the software development activities at Science 37. This position is responsible for reviewing and approving validation protocols, tests, summary reports, change requests for regulated software applications developed in house. This position will participate in continuous improvement of the quality management system at Science 37. This position reports to the Vice President of Quality and Compliance.

Duties & Responsibilities

Duties include but are not limited to:
•Provide oversight for day to day computer validation activities for software development of GCP applications.
•Assist with development and refinement of SOPs governing regulated software development and IT practices.
•Collaborate extensively with IT on software development activities
•Review and approve validation protocols, tests, summary reports, change requests etc.
•Participate in investigations related to computer systems deviations
•Participate in requirements gathering, testing strategy and execution oversight
•Participate in regulatory inspection preparations, and execution of inspections
•Participate in sponsor audits
•Participate in internal audits of Science 37 operations
•Remain abreast of current regulations and industry best practices in computer validation and clinical trials

Qualifications
•Bachelor’s Degree required
•5-10 years of experience in computer validation in a GxP environment
•Proven track record of cross functional collaboration
•Extensive knowledge of GXP regulations, 21CFR part 11 compliance requirements
•Excellent written and oral communication skills
•Strong understanding of all phases of software development, systems implementation and lifecycle
•Ability to meet deadlines in a fast paced environment
•Ability to perform risk assessments, formally and informally and recommend risk mitigation plans

Skills/Competencies
•Good interpersonal skills
•Strong organizational skills
•Strong creative problem solving skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses
•Ability to provide structure while encouraging innovation
•Ability to tactically implement a strategic vision
•Technical understanding of software development activities

Capabilities
•Ability to communicate in English (both verbal and written)