Job Description :
Hi friends,

Greetings,
I have below opening with our customer @ Woodbridge NJ
Kindly take a look and revert me your interest to

Job Description:

Role: QA Lead with GXP Experience
Location: Wood Bridge NJ
Duration: 4 - 6 Months

Responsibilities:

We have an immediate contract opportunity for a IT Architecture & Quality Lead.
The IT Architect and GMP Quality SME will work with cross-functional areas to understand business requirements to execute short and long-term strategy.

He/She is expected to:

Drive strategy for IT architecture through coordination and execution of cross-functional deliverables.
Bring global insights on GxP Systems, Quality Management, Technology Transfer, Validation, and Health Authority Requirements and Reporting within pharma/biologics/medical device manufacturing operations.
Drive stakeholder alignment in a fast paced, cross functional environment. Principal Responsibilities of IT Architecture & Quality SME
Provide hands-on strategy development, execution and coordination of activities related to IT quality implementations including development of process maps, business interaction diagrams, gap analysis and development of recommendations.
Provide inputs during cross functional meetings and workshops from IT Architecture perspective with Quality & Compliance considerations

Qualifications
Experience in Pharmaceutical/Biotech and/or Medical Device industry with subject matter expertise in Quality Assurance and Risk Management. Cross-functional Life Sciences experience with Information Technology (IT), Quality Assurance (QA), Engineering, Operations and/or Lab Quality Control
Proven record successfully implementing IT strategies for large scale projects
Ability to collaborate and lead cross-functionally to understand requirements and develop IT strategy
Ability to achieve alignment with business partners in a matrix environment and build strong relationships by being transparent and reliable
Demonstrated strong project management focus as well as tactical execution of strategic decisions while balancing conflicting priorities
Good understanding of the drug and device manufacturing process and distribution processes
Demonstrated strong leadership capability with ability to make and act on decisions