Job Description

　　*Please note - this is a HYBRID Role based in Orlando, Florida

　　Summarized Purpose:

　　This role will support the Quality Management system (QMS), compliance strategies, initiatives, and processes within PPD’s Early Development division (early phase clinical trials), which includes quality support of clinical research sites (CRUs), as well as CRO services. This role will lead the tracking and reporting of quality and compliance activities, as well as risk identification, critical issue, and tracking. Maintains tools and materials, serves as QMS lead and provides mentoring and expertise to advance the vision of the department.

　　Essential Functions and Other Job Information:

　　Performs internal GCP audits, including but not limited to internal process audits of CRUs and CRO services

　　Prepares timely and well written reports, evaluates auditee responses and tracks CAPAs as applicable.

　　Hosts Client Audits and supports regulatory inspections

　　Should be able to execute these audits based on changing business environment and interaction with cross functional teams

　　Reviews and approves Quality Event investigation reports thoroughly and in a timely manner

　　Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, internal audits, CAPA and/or procedural documents)

　　Occasionally audits external network sites located in North America

　　Provides sound guidance on GCP principles and applicable regulatory requirements

　　Researches and addresses issues and risks, tracks metrics and maintains reports and documentation related to quality and compliance activities

　　Qualifications

　　Education and Experience

　　Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

　　Bachelor's degree or equivalent and relevant formal academic / vocational qualification

　　Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

　　Experience in performing clinical quality (GCP) audits, investigator site audits, hosting client audits and CAPA investigations.

　　Knowledge of Veeva Quality System, preferable.

　　In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

　　Knowledge, skills and Abilities

　　An experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, dedicated, journey-level position.

　　Knowledge of clinical trial processes

　　Knowledge of Quality systems and procedures in a regulated environment

　　Comprehensive knowledge and understanding of ICH GCP and other relevant regulations and guidelines

　　Experience of performing clinical quality audits e.g. investigator site audits, process/ system audits, CAPA investigations and hosting client audits

　　Excellent oral and written communication skills

　　Strong organizational and time-management skills

　　Extensive knowledge of the clinical trial process

　　Demonstrated problem solving skills

　　Excellent attention to detail

　　Strong computer skills; ability to learn and become proficient with appropriate software

　　Demonstrated ability to multitask and prioritize competing demands/work load

　　Proven flexibility and adaptability

　　Supervision Received

　　Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

　　Business Relationships

　　Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.

　　Working Conditions and Environment:

　　Hybrid role, with approximately 3 days on-site per week in our Orlando, FL location.

　　• Work is performed in an office environment with exposure to electrical office equipment.

　　• Occasional drives to site/office locations with occasional travel both domestic and international.

　　Our 4i Values:

　　Integrity – Innovation – Intensity – Involvement

　　If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.