Validation Lead

Job Title - Validation Lead 
Location – Raritan, NJ (Hybrid)

W2/C2C

Job Responsibility:
•    Must be able to work out of Raritan or New Brunswick Office atleast 3 days a week.
•    Must be able to Independently Lead Business Separation activities for Large global & regional GxP Computerized systems. With minimal supervision.
•    Recent experience with Acquisitions/Separations/Divestiture from J&J a huge plus. Strong CSV Expertise, especially within Acquisition/Divestiture/Separation.
•    Ability to manage end-end from Inventory, assessments, remediations to final dispositions; Infrastructure Qualifications & Business Systems Validations
•    7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources.
•    Specifically in the Pharmaceutical, biotechnology, or medical device industry. Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation; Define and implement Risk based validation activities.
•    Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports, SOPs/WIs).
•    Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs
•    Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
•    Strong verbal and written communication skills.
•    Ability to work as a team player, lead a team or accomplish tasks without supervision.
•    Ability to work with remote teams and support several changes/projects simultaneously.
•    Ability to provide Validation guidance, timely reviews, and escalations to TQ management