Reporting to the SVP, Operations & General Counsel, the QA Manager is responsible for the duties outlined below.
Manage the electronic Quality Management System (eQMS) (MasterControl)
Serve as resident Quality expert in support of QMS activities (GLP, GCP, and CLIA)
Serve as System administrator for eQMS system
Configure and implement Process and Auditing modules to expand usage of system
Provide day-to-day management of document control processes and workflows within the EDMS
Manage any regulatory or governing body certifications (CLIA)
Manage change control, CAPA, deviation, and investigation programs
Review and approve executed documents including validation documents, reports that could be filed in support of regulatory submissions, and operating procedures.
Oversee the internal and external audit program, which includes, focus on GxP, GLP, GCP, CLIA compliance, regulatory agency inspection readiness, and for-cause inspections
Provide support to Clinical Team and Laboratory to ensure compliance with GCP’s, GLPs and applicable regulatory requirements
Facilitate vendor management
Responsible for facilitation and maintenance training records
Responsible for records management and facilitation of off-site records storage.
Serve as Safety Officer, responsible for implementation, management, and enforcement of environmental health and safety programs at BERG
Serve as Privacy Officer, responsible for the organization's Privacy and Security Program including but not limited to daily operations of the program, development, implementation, and maintenance of policies and procedures, monitoring program compliance, investigation and tracking of incidents and breaches and insuring patients' rights in compliance with federal and state laws. Complete appropriate certification.
Identify, develop, and communicate a metrics (KPI) system to drive awareness and improvement measurement
Requires a Bachelor's (Master's degree preferred) in a related scientific discipline with 8-10 years’ experience in QA in a GxP regulated environment
Must have successful implementation experience and management of a QMS System
Must demonstrate attention to detail and excellent record keeping skills
Must be proficient in MS Office Suite (e.g. Word, Excel, PPT) required for review and preparation of documents and reports for inspections
Proven ability to find creative, practical solutions to complex problems
Excellent communication and interpersonal skills
Superior and proven organizational skills
Ability to multitask and work in a team-oriented fast-paced environment
Internal Number: 1084
About BERG LLC
BERG is a biopharma company focused on taking a bold “back to biology” approach to therapeutic discovery using its unique AI-based Interrogative Biology® platform. This platform combines patient biology and artificial intelligence-based analytics to engage the differences between healthy and disease environments. The patient’s own biology drives the platform’s results and guides us in the discovery and development of drugs, diagnostics and healthcare applications. Our platform utilizes patient population health data to bring actionable Patient Intelligence™ to precision medicine applications. This means faster discovery and development of treatments, more effective precision treatments for individuals as well as a reduction in costs to our healthcare systems.
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