Associate Director/Director, GxP Information Systems
This hands-on position is responsible for defining and maintaining Dynavax’s corporate GxP information systems and supporting end users of the company’s corporate GxP information systems.
- IT system owner responsible for development, validation, and maintenance of corporate GxP and information systems including but not limited to MasterControl, TrackWise Digital, Tracelink, Part 11 DocuSign, Veeva, and Argus.
- Partner, collaborate and align with business colleagues to define and document critical business processes and requirements, prioritize requests, create business cases for technology solutions, and manage them through the IT governance process.
- Provide technical consultation and implementation of new corporate GxP information systems to support the line organization as needed.
- Project Manager for technology implementations, including coordination and management of external vendors and ensuring adherence to corporate GxP SOPs.
- Oversee application lifecycles for business partners including Quality and Technical Ops systems in use including change control, testing, validation, and communication.
- Lead or support deviation/incident investigations related to corporate GxP information systems and manage the implementation of identified Corrective Actions / Preventive Actions (CAPA) resulting from these investigations.
- Consult / communicate with Dynavax’s manufacturing plant in Düsseldorf, Germany on the plant’s GxP information systems as needed.
- Execute agreed upon service levels for corporate GxP systems (i.e. project schedules, system availability, and service quality).
- Direct the analysis, design, development and installation of corporate GxP applications in accordance with established
- Partner with QA to manage system validation, periodic reviews and vendor assessment/qualification.
- Assist as needed in external/internal audits and inspections.
- Drive continuous improvement in system performance and service quality for products including but not limited to MasterControl, TrackWise Digital, Tracelink, Part 11 DocuSign, Veeva, and Argus.
- Partner with QA to manage systems validation, periodic reviews and vendor
- Prepare operational forecasts and requirements, including monthly reports and budget analyses.
- Ensure compliance with application services standards, procedures, documentation requirements and
- Support the organization in the on-going Sarbanes Oxley computer controls, testing and audit
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and
- Other responsibilities are performed as assigned or needed.
- BS degree in computer science, business or equivalent work experience.
- Five to ten years of experience supporting GxP IT systems with 3 to 5 years’ experience in the following:
- IT management experience in a biotech/pharmaceutical environment managing systems supporting drug safety, pharmacovigilance, manufacturing, engineering automation, regulatory compliance, quality management and compliance, medical information or clinical trials applications; and,
- IT working knowledge in a biotech research and lab environment, familiar with lab systems implementation and system
- Knowledge of systems software, operations, capacity management, mid-range servers, PCs and web
- Experienced in gap analysis, remediation plans and corrective and preventive action (CAPA), in reviewing, modifying and writing standard operating procedures (SOPs).
- Must have hands on experience in qualifying production servers to meet regulatory requirements.
- Knowledge and expertise with Software as a Service (SaaS) systems, automated process equipment and clinical data management software in the biotechnology or pharmaceutical industry.
- Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11 and GAMP 5.
- Good communication skills and have the ability to develop persuasive arguments and ability to interact with all levels of
- Detail-oriented; with strong analytical, organization, and problem-solving.
- Ability to troubleshoot, research, and solve technically challenging problems involving integrated systems.
- Strong customer service orientation and an understanding of business processes related to pharmaceutical corporate
- Track record of successful project and process management specifically information systems projects