Associate, Compliance & QA – Technology

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🕒 Julho 29

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WCG

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💊 Farmacêutico

☁️ SaaS

💰 Private Equity Round - WCG em 2019-11

Healthcare • Pharmaceuticals • SaaS

A WCG é uma empresa global de serviços e tecnologia para pesquisa clínica que apoia patrocinadores, CROs, centros de pesquisa e instituições durante todo o ciclo de vida dos ensaios clínicos. Fundada como líder em revisão ética independente, a WCG fornece revisão de IRB e IBC, comitês de monitoramento de dados, capacitação de sites e serviços de iniciação de estudos, recrutamento e retenção de participantes, e dados & insights (incluindo benchmarking, consultoria estatística e previsão de ensaios impulsionada por IA). A empresa também oferece um conjunto de plataformas tecnológicas (por exemplo, ClinSphere®, eReview Manager, Total Enrollment, Total Feasibility) e grandes conjuntos de dados de protocolos e desempenho para ajudar a projetar, planejar e conduzir ensaios de forma mais eficiente e em conformidade. A WCG se posiciona como parceira de organizações de biofarma e pesquisa médica para acelerar a ativação de ensaios, melhorar o recrutamento e garantir conformidade regulatória e ética.

Descrição

• Engages in the continued development, maintenance, and enforcement of the WCG Quality Management System and quality department standards. • Supports efforts regarding the maintenance of WCG quality goals, objectives, and process improvements. • Educates WCG staff on WCG quality department standards and best practices. • Engages with WCG staff to author and revise internal technology standards (i.e. IT and/or Software Development Policies, SOPs, et al). • Supports the development, validation, implementation, and change management of systems to ensure same is performed in line with regulatory agency regulations and guidance, including but not limited to, GxP, 21 CFR Part 11/Annex 11, GDPR, and HIPAA. • Supports the investigation of Quality Events/Corrective Actions Preventative Actions (CAPA), deviations, and notes to file (NTF). Executes assigned compliance tasks in adherence of defined timelines. • Conducts internal audits to ensure internal standards and staff performance are compliant with applicable WCG process, regulatory agency regulation, and guidance. • Conducts external vendor qualification audits to ensure that vendor standards and performance are compliant with applicable WCG process, regulatory agency regulation, and guidance. • Supports external audits including audit preparation activities, review of audit report, and executing finding resolution. • Maintains current knowledge with respect to quality legislation and regulatory compliance best practice. • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

🎯 Requisitos

• Bachelor’s degree in a scientific, technical or related field, or equivalent combination of education, skills, and experience to perform the job. • Two (2) to four (4) years’ experience in a quality/regulatory compliance position supporting and contributing to quality assurance projects/assignments. • Knowledge of current regulatory (FDA & ICH) & GCP guidelines as they apply to clinical studies. • Experience in supporting customer/sponsor audits of organizational processes, training, documentation, etc. • Knowledge of 21 CFR Part 11 scope and application and Computerized System Validation processes. • Experience in the execution and documentation of Computerized System Validation efforts of systems used in Clinical Trials. • Experience delivering training materials related to company standards and regulatory requirements. • Ability to contribute to and execute workstreams within multi-departmental projects • Effective communication (written and oral) skills, organization and interpersonal skills as well as the ability to interact with WCG staff, sponsors, and regulatory agencies as needed. • Demonstrated technical writing skills. • Ability to problem solve and engage in conflict resolutions. • Ability to multitask and to work efficiently and independently.

🏖️ Benefícios

• Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts • Employee Assistance Programs and additional work/life resources • Referral Bonuses and Tuition Reimbursement • Flexible PTO • Volunteer Time Off to benefit the community • Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement