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Sr. Project Manager Consultant GxP

Company: NCS Technologies, Inc.
Location: Yonkers
Posted on: October 14, 2020

Job Description:

We are looking for a Sr. PM Consultant GxP. Proven experience in GxP compliance for CSV projects from initiation to closure is very important for this role. We have an immediate need for a Sr. Project Manager Consultant with significant experience leading complex multi stakeholder related projects with experience migrating projects to GxP. The qualified candidate must be a thought leader, critical thinker, knowledgeable about GxP migrations and a key resource. This role will report to the Director, Research Development, IT Portfolio Management. Biotechnology GxP Compliance is a core element of this role. GxP Quality Assurance and Quality Control typically includes six phase including DQ, IQ, OQ, PQ, MQ, and CQ. Additionally, Title 21 CFR Part 11. Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). This role will part of portfolio team to deliver value for senior scientists (stakeholders). Skills Project management with GxP migration Direct experience implementing GxPcloud services, ideal Experience with application migrations to the private andor public cloud, preferred Knowledge of Amazon Web Services, preferred Experience migrating applications, servers and databases from cloud to cloud environments, preferred Deep understanding of software developmentengineering lifecycle from conception to delivery Demonstrated leadership through influence Proven ability in CSV with demonstrated acumen of V model Experience working in regulated Research Development Proven experience in GxP compliance for CSV projects from initiation to Prior experience working with or managing large technical programs, particularly at high growth startups or Fortune 500 companies High learning intelligence ndash the ability to learn quickly and efficiently Contracting and procurement framework, enabling the identification of gaps in an immature process that is evolving Comfortable influencing an experienced team toward aggressive timelines Participate in the weekly Research IT portfolio meeting Masterrsquos Degree, preferred Bachelorrsquos Degree in Computer Science, Computer Information Systems, Biopharma, Pharma, BioTech, Mathematics or Project Management Professional (PMP) certification active Agile Certification (one or more) Certified Scrum Master (Scrum Alliance) Agile Certified Practitioner (Project Management Institute) Certified SAFe Agilist (Scaled Agile Framework) Certified SAFe Practitioner (Scaled Agile Framework) 5 years managing full SDLC implementations of large GxP 21 CFR Part 11 compliance 10 yearsrsquo experience as a Project Manager Experience leading teams in at least two separate industries Experience working in a business environment coordinating with and supporting internal and external clients and vendors Experience managing complex development projects with significant business input and interaction Expert in managing project scope, time and resources, budget, quality and riskissues while balancing the need of multiple stakeholders building relationships through effect communication. Experience to understand how to develop and managing a critical path, with only limited information to

Keywords: NCS Technologies, Inc., Yonkers , Sr. Project Manager Consultant GxP, Other , Yonkers, New York

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