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Required skills include:The selected candidate must be a results-oriented individual with a very strong work ethic and must be able to demonstrate excellent IT Project Management, negotiation, communication, and problem-solving skills. This position will be responsible for working with senior-level business executives, IT personnel, business program resources and Vendor staff to execute project requirements and manage stakeholder expectations.

<div>Currently candidates will be allowed to work remote. Work must be completed on site in Raleigh, NC at the client's discretion. Client has not notified of any intention to return to onsite work. Candidate must work EST Business Hours.</div><div> </div><div>Our direct client has an opening for a Project Manager w/ Healthcare Exp position # 739635 & 739640. This position is for 6-12+ months, with option of extension, and will be worked remotely at this time.  Work must be completed on-site in Raleigh, NC at client’s discretion.  (must work EST business hours).</div><div> </div><div><strong>If you are interested, please submit the following:</strong></div><ul><li>Your current resume</li><li>Your hourly rate </li></ul><div> </div><div>Below is the job description – Resumes due ASAP </div><div> </div><div><strong>Description:</strong></div><div>This lead project management role will work with multiple internal and external stakeholders and selected vendor(s) to analyze, plan, and implement the new system. This position will be responsible for working with senior-level business executives, IT personnel, business program resources and Vendor staff to execute project requirements and manage stakeholder expectations. This position will manage the day-to-day activities for the project and complete all input to the State Project Management (Touchdown) system as needed. The project will be utilizing the agile methodology.</div><div> </div><div><strong>Responsibilities include but are not limited to:</strong></div><ul><li>Working with the business leaders and SMEs to obtain a thorough knowledge of the needs of a new IT system</li><li>Developing and maintaining detailed project schedule, budget and monitoring expenditures</li><li>Developing and maintaining all required project management artifacts following State, DHHS and PMBOK guidelines</li><li>Managing scope, resources, timelines, costs/budget, quality, communication, and procurements to meet the goals of the State</li><li>Working closely with the team conducting alternative analysis and writing documentation (including an RFP if required).</li><li>Working with vendors to manage deliverables to ensure that all the milestones are met</li><li>Ensuring that project plans and schedules are established and maintained, ensuring that deliverables are completed timely and accurately</li><li>Establishing project governance, conducting formal presentations, coordinating with all project stakeholders and ensure that appropriate project controls are instituted</li><li>Serving as an IT project liaison to the business client</li><li>Working with business stakeholders to develop necessary project management, change management, risk management, rollout, and training plans</li><li>Working with the technical team to ensure technical readiness during implementation</li><li>Developing and maintaining all required State CIO project documentation</li></ul><div><br/></div><div><strong>Required skills include:</strong></div><ul><li>The selected candidate must be a results-oriented individual with a very strong work ethic and must be able to demonstrate excellent IT Project Management, negotiation, communication, and problem-solving skills.</li><li>Capable of leading effective project meetings that are tailored to the audience</li><li>Ability to create simple to complex project plans, timelines and work breakdown structures using project management tools</li><li>Must have proficiency in project management, agile, scrum, and Kanban software tools</li><li>Must have strategic planning skills with good understanding of roadmap development.</li><li>Ability to write and present effective project materials, including presentations and status reports</li><li>Ability to work effectively with all levels of staff, clients and other IT personnel</li><li>Proven experience with working collaboratively with business/program partners</li><li>Ability to effectively identify and resolve system or business process/project issues</li><li>Ability to build, influence, lead and motivate effective teams towards end results</li><li>Flexibility, adaptability, and ability to work in a high-demand dynamic environment</li><li>Strong analytical skills</li><li>Strong written and oral communication skills, including development of project</li><li>Must have experience writing RFPs/technical writing</li><li>Understanding of the fundamentals of iterative and incremental development</li><li>Ability to help manage Scrum team backlog and/or Kanban Flow, and priorities using agile based tools (ServiceNow, Jira, Version One etc.)</li><li>Experience in playing the Scrum Master role for a software development / maintenance team that was diligently applying Agile / Kanban values and principles and practices</li><li>Proficient in conducting all the Scrum ceremonies within a collocated as well as distributed teams</li><li>Experience in facilitating release planning</li></ul><div><br/></div><div><strong>Management prefers applicants with the following:</strong></div><ul><li>Candidate with PMP Certification. Scrum Master certification is a plus.</li><li>Experience managing or supervising legacy system upgrade and/or replacement projects</li><li>Experience collaborating with State and Local Government</li><li>Healthcare related experience is required</li><li>Knowledge of Public Health Programs is preferred</li><li>Experience planning and managing data conversion activities</li><li>Experience building rollout plans </li></ul><div><br/></div><div><strong>Required/Desired Skills:</strong></div><ul><li>Project management experience, preferably with large, complex automation implementation efforts - Required - 8 Years</li><li>Demonstrated Project Management experience on system deployments with multiple clients. - Required - 8 Years</li><li>Proven track record of delivering projects and work streams with aggressive timelines and deliver within scope, budget and schedule - Required - 8 Years</li><li>Objective decision-making ability based on strategic objectives priority, business performance analysis and resource availability. - Required - 8 Years</li><li>Hands on experience managing project risk, cost, schedule, quality, testing, and communications. - Required - 7 Years</li><li>Strong leadership, organizational, interpersonal and time management skills. - Required - 3 Years</li><li>Demonstrated oral and written communication and presentation skills. - Required - 3 Years</li><li>Solid work experience with project management tools (e.g. Microsoft Project) - Required - 7 Years</li><li>Experience with MS Office and SharePoint.. - Required - 7 Years</li><li>Demonstrated experience with both Waterfall and Agile Projects - Required - 5 Years</li><li>Demonstrated experience with vendor management on a large IT project/system implementation - Required - 8 Years</li><li>Demonstrate technical architecture/infrastructure knowledge and experience, including experience with multiple hardware platforms and operating system - Required - 8 Years</li><li>Demonstrate technical knowledge and analysis skills with hands-on experience in development, data base design, and web-based technologies - Required - 8 Years</li><li>Demonstrated experience working with DPH programs - Highly desired - 5 Years</li><li>Demonstrated experience working with DCFW programs - Highly desired - 5 Years</li><li>Extensive understanding of SharePoint end user experience, sites, libraries, lists and groups - Highly desired - 3 Years</li><li>Experience in health care industry - Highly desired - 5 Years</li><li>Experience leading and Implementing COTS and SAAS Projects - Desired - 7 Years</li><li>Experience writing RFPs/technical writing - Highly desired - 5 Years</li><li>Understanding of the fundamentals of iterative and incremental development - Required - 3 Years</li><li>Experience in playing the Scrum Master role for a software development / maintenance teams that was diligently applying Agile / Kanban values and principles - Highly desired - 3 Years</li><li>PMP Certification from PMI. Scrum Master certification is a plus - Highly desired - 5 Years</li><li>Ability to help manage Scrum team backlog and/or Kanban Flow, and priorities using agile based tools (ServiceNow, Jira, Version One etc.) - Required - 3 Years</li></ul><div><br/>By replying to this job advertisement, I agree I want to receive additional job advertisements from Focused HR Solutions, including email, phone and mail to the contact information I am submitting. I consent to Focused HR Solutions, its affiliates, third parties and partners processing my personal data for these purposes and as described in the Privacy Policy. I understand that I can withdraw my consent at anytime.</div>

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All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. Job Description: If you’re passionate about turning complex requirements into elegant, validated systems—and you thrive in a collaborative, matrixed environment—this role is your opportunity to make a visible impact on tech transfer timelines, batch right‑first‑time performance, and regulatory readiness.

Position Overview:
<p style="margin:0px">Help build the digital backbone of next‑generation biopharma. As our System Manager, you will own and elevate core Product Technology platforms—PDLM, ELN, and Risk Management—that power Process Development and MSAT. You’ll translate real-world science into robust, compliant digital solutions, weave data integrity through every workflow, and enable a new, standardized way of working across global teams.</p>

Company Overview:
<p style="margin:0px">The work we do at FUJIFILM Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. <br/><br/>Join FUJIFILM Biotechnologies and help make the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what we call Genki. <br/> <br/>Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: <a href="https://www.fujifilm.com/us/en/about/region/careers" rel="nofollow" style="color:#000000">https://www.fujifilm.com/us/en/about/region/careers</a></p>

Job Description:
<p style="margin:0px">If you’re passionate about turning complex requirements into elegant, validated systems—and you thrive in a collaborative, matrixed environment—this role is your opportunity to make a visible impact on tech transfer timelines, batch right‑first‑time performance, and regulatory readiness.</p><h2>Why you’ll love it here</h2><ul><li>Shape how development knowledge (DoE, QbD) flows into manufacturing execution and CPV</li><li>Own high‑value platforms with direct line of sight to business outcomes</li><li>Partner across PD, MSAT, Automation/Engineering, QA/Validation, and IT/OT</li><li>Drive standardization at scale with class‑based, globally reusable configurations</li><li>Operate with autonomy while influencing best practices across sites</li></ul><h2>What you’ll do</h2><ul><li>Design, configure, implement, and maintain PDLM, ELN, and Risk Management platforms to meet user and compliance requirements</li><li>Translate business needs into scalable, class‑based configurations and reusable library objects that enable data standardization</li><li>Ensure cGxP, data integrity (ALCOA+), and data security across integrations; partner with QA/CSV on risk‑based validation (GAMP 5, CSA) and audit readiness</li><li>Define and enforce standards, templates, libraries, and master data structures in partnership with Master Data teams</li><li>Deploy class‑based data structures to deliver recipe data models and master data (materials, specs, equipment classes)</li><li>Develop training, job aids, and adoption materials; coach teams on ISA‑88 and digital recipe best practices</li><li>Manage external partners and solution vendors; define user requirements, participate in design reviews, and ensure delivery to standards and timelines</li><li>Contribute to digital thread initiatives linking development knowledge to manufacturing execution and CPV; support regulatory inspections and filings</li><li>Drive harmonization and standard work across sites (templates, test protocols, UAT scripts) to reduce cycle times and deviations</li><li>Champion continuous improvement through metrics, KPIs, and standardized ways of working</li></ul><h2>What success looks like</h2><ul><li>Seamless, compliant platforms that accelerate development and tech transfer</li><li>Standardized data models and libraries that scale globally</li><li>Strong adoption and user satisfaction through clear training and enablement</li><li>Audit‑ready documentation and validated configurations</li><li>Reduced cycle times, deviations, and rework through harmonized processes</li></ul><h2>Minimum Qualification Requirements</h2><ul><li>Bachelors Degree in Engineering or Scientific related field</li><li>5+ years’ of relevant experience in Information Technology implementing and sustaining GxP impacted systems in life sciences or closely related industries.</li><li>Demonstrated experience with Computer System Validation (CSV) and data integrity principles (ALCOA+).</li><li>Proven experience with one or more: PDLM/PLM, ELN, or Risk Management Platforms</li></ul><h2>Preferred Requirements</h2><ul><li>Experience in manufacturing or process development systems preferred (MES/LIMS/QMS/data platforms)</li><li>Preferred experience in pharmaceutical industry, IT CSV</li><li>Familiarity with ISA-88/ISA-95 standards and digital recipe/data modelling</li><li>Certifications: GxP/CSV (e.g., ISPE/GAMP), Agile/Scrum, ITIL, PMP/PRINCE2, or data integrity.</li></ul><h2>What you’ll bring</h2><ul><li>Deep understanding of PDLM/PLM and ELN platforms and their application to Process Development/MSAT</li><li>Strong knowledge of CSV, data integrity (ALCOA+), and risk‑based validation (GAMP 5, CSA)</li><li>Knowledge of ISA‑88/ISA‑95 and digital recipe principles</li><li>Excellent stakeholder communication and facilitation skills; ability to influence without authority</li><li>Strong problem‑solving and analytical skills; experience with KPIs and continuous improvement</li><li>Comfort operating in a global, matrixed environment</li></ul><p style="margin:0px">Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k)savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!</p><p style="margin:0px"> </p><p style="margin:0px">As part of any recruitment process, FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. The organisation is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.​</p><p style="margin:0px"> </p><p style="margin:0px">This is a global position that will support all FUJIFILM Biotechnologies sites. This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.​</p><p style="margin:0px"> </p><p style="margin:0px">To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. </p>

EEO Information:
<p style="margin:0px">Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.</p>

ADA Information:
<p style="margin:0px">If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fdbglobaltalent@fujifilm.com).</p>

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