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Head of CQV

Company: FUJIFILM Holdings America Corporation
Location: Holly Springs
Posted on: May 26, 2023

Job Description:

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB 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. Join FDB and help manufacture 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.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new -large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end CDMO provider in North America.
The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also -provide -automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
CQV PM responsible for the CQV Team and Deliverables from Design, Construction & Startup through successful PPQ Runs.
Provides valued input into each project stage, ensuring that Quality and Compliance requirements are satisfied. The output of the CQV team is the documented evidence that all systems and equipment are designed and tested ensuring associated requirements are met, followed by performance testing which confirms those systems are fit for their intended use in commercial manufacturing. -Lastly, CQV manages the execution of Process Validation to confirm that Critical Quality Attributes requirements are consistently satisfied thus ensuring the production process is adequately controlled to within specified tolerances.
This is a key role to ensure success of the project. - The CQV department is the recipient of all systems (direct and no impact) from the construction partner and is responsible for the successful set up and documented commissioning, as well as qualification and validation of direct impact systems. -

  • Responsible for the CQV Team and Deliverables from Design through to successful PPQ Runs. This person should have insights into each Design Stage for Project, Concept, BOD and Detailed Design, ensuring at all times that all Quality and Compliance deliverables are included in Design.
  • Responsible for building CQV Team from Day 1 on Project to ensure the Team is in place to deliver the project at each stage - Design, Document Generation, FAT, Mechanical Completion, Set to Work, Pre Safety Start up Reviews, Commissioning, Qualification and full handover to Operations.
  • Solely responsible for the recruiting of all CQV Staff and Contractors to deliver on all Project Stages, as listed above.
  • Produce and manage all CQV Costs for Project, not just resources, but also including - Consumables and Spares, Validation Licence's, FAT Costs, Vendor SAT costs, Master Project Database, Rough and Final Balancing of Utilities, Hot Loop and Calibrations, Shift Allowances and any Direct Impact QA Assessments required.
  • At PO creation, the head of CQV will ensure that all CQV documentation requirements are met from each vendor and ensure timely ordering of all CQV Spares for Project, prior to Commissioning Start.
  • Ensure creation and management of all documentation produced for the Project, including Plans, SOPs, Strategies, DQ, QRA, RTM, FAT, SAT, IV/OV, IOQ, PQ and all supporting Final Reports.
  • Lead all Field execution for all Work streams - CUB, Warehouse, Lab, Grey/Black Utilities, Clean Utilities, Inoc, Media, Cell Culture, Harvest, UFDF, Chromatography, Purification, Formulation, Filling and Packaging.
  • Ensure relevant tracking in place for CQV deliverables, both documentation readiness and field execution of protocols and test scripts, serving as the point contact with Construction Management Team in relation to site readiness and just in time date requirements from all FATs.
  • Create, lead and implement CQV Project schedule for project, from Design to full Handover, using Primavera P6.
  • Represent CQV at PM level at all meetings and also and SLT meetings where required.
  • Lead all CQV Weekly Meetings and ensure all items are actioned correctly.
  • Act as Project SME for all CQV processes, including ASTM E2500, which will be utilized for CQV document creation and field execution.
  • CQV point contact for all CQV and or Project queries from Design Team, Contraction Teams and Contractors.
  • Liaise with CQV QA Turnover Lead in relation to documentation requirements for each PO and per system VDR.
  • Coordinate with the Master Project Database (MPD) lead in relation to ETOP reviews and approvals, Punch items raising and closure, Make, Model and Serial Number input into CMMS and Vendor Weekly Submittals.
  • Liaise with Lead Scheduler to ensure all relevant CQV milestones and durations are captured and tracked in the Master Project Schedule. Additionally, liaise with Operations to ensure correct Operations milestones for Operation SOPs are also in the schedule and at the correct times, through draft, review and approval.
  • Ensure proper Project Turnover Strategy is in place for Project duration, from Design to Construction, MC, Construction to CQV, and finally CQV to Operations/Facilities.

    External US

    • Bachelor's Degree Required, preferably in Engineering
    • 10+ yrs of progressive relevant industry experience is required
    • 3+ years in a project management or leadership role managing others, strongly preferred
    • Previous experience in large-scale pharma/biotech project, strongly preferred
    • Subject Matter Expert on ASTM E2500 / Leveraging Verification process
    • Hands-on experience with CQV in Upstream, Downstream and Drug Product commercial manufacturing environments.
    • Experienced with development of Validation Master Plans and procedures
    • Preferred expert knowledge of relevant US & EU regulatory requirements for qualification of systems and equipment
    • Preferred expert knowledge of cleaning and process validation
    • Preferred knowledge of computer validation and associated US and EU regulation
    • Preferred knowledge of project controls strategies including earned value calculations for CQV

Keywords: FUJIFILM Holdings America Corporation, Cary , Head of CQV, Other , Holly Springs, North Carolina

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