Manager, Global Quality Compliance Support

🕒 Maio 8

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UBC

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2003

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

Biotechnology • Healthcare Insurance • Pharmaceuticals

A UBC é uma empresa dedicada a melhorar os resultados dos pacientes, conectando terapias especializadas aos pacientes que delas necessitam. Eles oferecem soluções modernas e personalizadas, focando em acesso, segurança e geração de evidências para produtos biofarmacêuticos. A UBC é especializada em desenvolvimento de evidências, gestão de riscos e acesso do paciente, utilizando dados do mundo real e tecnologias inovadoras para otimizar a jornada de saúde e garantir o uso eficaz de medicamentos.

Descrição

• Oversee and manage the controlled documents lifecycle and corresponding test assessments • Ensure compliance with internal policies and procedures and target review cycle frequency including appropriate formatting of SOP documents. • Support SOP review and approval process as deemed appropriate • Oversee and manage training related activities (e.g. SOP table of content, training matrix, training decks, other training documentation) • Oversee and provide assistance with CAPA administrative activities (data entry, effectiveness checks, process improvement, ensure process is managed in compliance with policies and procedures, etc.) • Support and assist with GQC IT systems maintenance and change control (CAPA, electronic Document and Learning Management System, other) • Oversee and manage the Regulatory/Client Audit Support functions • Audit scheduling and audit calendar maintenance • Meeting coordination/logistics • CDA Requests • Auditor Code of Conduct • Setting up internal trackers and portals • Setting up and providing secure Box access for auditor(s) when required • Quality Compliance documentation review prior to and during audit • Ensure audit reports and responses are stored as per UBC record retention procedures. • Provide administrative support (i.e., agenda, minutes, metrics) for the Global Quality Compliance department. • Assist in department-related special projects. • Other duties as assigned.

🎯 Requisitos

• Bachelor’s degree required preferably in Life Sciences, Clinical, or Business area of study • 2-3 years quality assurance/compliance/auditing experience within a regulated industry (e.g., pharma, medical device, food) • Previous experience of working at a CRO • Experience hosting regulatory inspections and supporting client audits • Extensive knowledge of applicable pharmaceutical/biotechnology regulatory requirements (e.g., ICH, GCP, GxP, FDA/CFR, EMA, MHRA, EU GVP) • Preferably at least 1 year of previous managerial/supervisory experience • Proficient PC knowledge required including Microsoft Office Suite (i.e., Word, Excel, Powerpoint, Outlook), Internet, SharePoint • Experience in management of the corrective and preventive action (CAPA) lifecycle • Experience in Quality Management Systems maintenance • Experience in management of standard operating procedures (SOPs)/policies • Experience in implementation and management of process improvement • Excellent verbal presentation and written communications skills • Proven interpersonal and relationship building skills • Proven skills in planning, analysis, and creative problem solving • Strong organizational and time management skills • Preferred exposure to software application development and maintenance.

🏖️ Benefícios

• Competitive salaries • Growth opportunities for promotion • 401K with company match* • Tuition reimbursement • Flexible work environment • Discretionary PTO (Paid Time Off) • Paid Holidays • Employee assistance programs • Medical, Dental, and vision coverage • HSA/FSA • Telemedicine (Virtual doctor appointments) • Wellness program • Adoption assistance • Short term disability • Long term disability • Life insurance • Discount programs