Job Description :
any visa/tax term

*IT R&D Project Manager (Bio-Phama

*Location: Sunnyvale CA*

*6 months+*

Job Description:-

This role will be responsible for managing projects related to Lab Systems
such as Empower, STARLIMS and other common Labs related systems involving
CSV Computerized System Validation / 21 CFR Part 11. Ability to develop
relationships with R&D stakeholders, solicit, define, and document
project requirements, and fluidly working with IT technical contributors.
This role demands 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
- 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
- Maintain organized, clear, focused project status, schedule to ensure
project success.
- 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
- Skills: Project Management, SDLC, Business Analysis, Vendor
Management, Computer Systems Validation.
- Proficiency in Microsoft Office applications, including Powerpoint.
- Systems Experience (OpenLab, STARLIMS) or relevant system exposure is
a plus.
- BA or BS degree in technical or scientific discipline required.
- PMP certification.