Role: Sr. IT R&D PM Location: Sunnyvale, CA Type: Contract
This role will be responsible for managing GxP projects involving computerized system validation (CSV) and 21 CFR Part 11 across the QA, clinical, regulatory, and laboratory areas. Ability to develop relationships with R&D stakeholders, solicit, define, and document project requirements, and fluidly working with IT technical contributors. This role demands a strong hands-on PM with excellent track record of accomplishment of managing multiple projects and leading with authority. This role will have a vested interest in meeting all milestones and will work with external vendors, technical leads, validation team, and the business in order to accomplish the greater goals of the project on time and within budget. Key Accountabilities/Core Job Responsibilities:
Pro-actively lead requirement gathering efforts and coordinate with business SMEs, IT architect, IT Business Analysts, Developers, Validation Team to translate information into Functional and Technical requirements specifications.
Independently coordinate with Vendor and in-house Programmer/Administrator staff
Author project documentation including Business Justification, Project Proposal, Project Charters, Budget Tracker, Schedule, Status Dashboard, Timeline visuals, Lessons Learned
Professionally prepare presentations for IT, Business stakeholders, provide roadmaps, strategize project roadmap
Manage Vendor relationships and lead calls with vendors
Ensure GxP validated solutions comply with FDA regulations throughout the solution lifecycle, working tightly with internal PCYC IT Validation SMEs/Team, Quality.
Escalate issues to Sr. Management, and to vendor support as needed
Qualifications, Experience and Education Requirements:
5-7 years of experience managing projects to implement system/s in GxP controlled environment including responsibility for the implementation of R&D systems
Strong interpersonal and communication skills; ability to interact with different levels of management.
Project management in the Bio-Pharma, Life Sciences industry is required.
Skills: Project Management, SDLC, Business Analysis, Vendor Management, Computer Systems Validation.
Proficiency in Microsoft Office applications, including Powerpoint.
Pharma systems experience in QA, clinical, labs, and/or regulatory is a plus.
BA or BS degree in technical or scientific discipline required.
