Director, GxP & Research Applications

Location
Berkeley, California
Posted
Feb 28, 2018
Ref
18-020N
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
This position will be responsible for defining and maintaining global GxP and R&D application services. The successful candidate will have extensive experience with pharmaceutical and Biotech IT systems, vendor management, cross-functional team management, CFR part 11, GAMP 5, and Sarbanes Oxley regulations, systems validation, and change control. 

 

This position will provide leadership to the Application Services team and the company.  It will consult with the business to achieve successful GxP and R&D system development and completion of the IT department’s objectives, projects and priorities. He or she will provide work direction, development coaching and performance feedback to Application Services staff while establishing and maintaining positive relationships with relevant business partners.

Responsibilities
  • Provide production and development support for existing and future multi-tier GxP and Research applications. 
  • Establish and maintain positive relationships with business partners and with employees at all levels across the organization. 
  • Set appropriate goals and priories aligned with strategic business objectives and in coordination with key business partners, other organizational units and third party resources. 
  • Execute agreed upon service levels (i.e. project schedules, system availability, & service quality). 
  • Review systems requirements and prepare recommendations anticipating future application needs. 
  • Direct the analysis, design, development and installation of IT supported applications in accordance with established SOPs. 
  • Direct the IT process development team to establish and maintain IT SOPs, WIs and related documents. 
  • Partner with QA to manage systems validation, periodic reviews and vendor assessments. 
  • Prepare operational forecasts and requirements, including monthly reports and budget analyses. 
  • Manage the hiring, training, developing, and coaching of the research application staff. 
  • Provide regular performance feedback to employees including written performance reviews. 
  • Lead individual projects as assigned using software development life cycle (SDLC) methodologies. 
  • Ensures compliance with Application Services standards, procedures, documentation requirements and policies. 
  • Support the organization in the on-going Sarbanes Oxley computer controls, testing and audit processes. 
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork. 
  • Other responsibilities are performed as assigned or needed.
Qualifications
  • 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 biotech project management experience in a multinational environment;
  • 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 requirements.
 Two to three years of experience support Sarbanes Oxley Information Technology General Controls (ITGC).

  • Knowledge of systems software, operations, capacity management, mid-range servers, PC’s and web services.
 Working knowledge of CFR part 11 requirements and direct experience with systems implementation in a validated environment. 

  • Must possess good communication skills, the have the ability to develop persuasive arguments and an ability to interact with all levels of Dynavax 
  • Must be detail oriented; with strong analytical, organization, and problem solving skills Must have the ability to troubleshoot, research, and solve technically challenging problems involving integrated systems. 
  • Must possess strong customer service orientation and an understanding of business processes related to pharmaceutical corporate activities. 
ADDITIONAL KNOWLEDGE AND SKILLS DESIRED:

  • Experience with Argus Drug Safety System, Veeva Vault Clinical Suite, Master Control, DocuSign Part 11, CMMS (Computerized Maintenance Management System), Electronic Notebooks solutions highly desirable.