Quality & Compliance Manager

*** EASY APPLY on our Company Page with RESUME ONLY (Cover page optional) ***
           

       
This position, with direction from QV management, is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing.  Requires strong Commissioning and Qualification background.

Key Accountabilities:

  • Participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines
  • Review and approve validation related studies for assigned areas.
  • These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process
  • Validation, Equipment and Facility Qualification and Validation Risk Management.
  • Signatory responsibilities for validation/qualification documents within assigned areas.


Technical Competencies:

  • Working knowledge of cGMPs and regulatory requirements
  • Experience with validation of biotech manufacturing processes (i.e. viral antigen or formulation production) and knowledge of current FDA regulations and industry guidance related to validation processes.
  • Knowledge of vaccines/biologics products and associated technologies
  • Ability to work on cross functional project teams
  • Meet/Exceed project timelines/deliverables
  • Experience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS Office
  • Strength in several LEAD Competencies - Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions



Education: 
*5+ years' experience in a GMP regulated environment working on validation projects associated with biotech processes and equipment.

Required Skills: 
FDA
LABWARE
MANUFACTURING PROCESSES
CGMPS
MS OFFICE 
Additional Skills:
QUALITY MANAGER 
RISK MANAGEMENT 
SAP 
TRACKWISE 
GMP 
MICROSOFT OFFICE 
TRADING  
                       
About us -VIE HIRE   We are not a large corporate consulting conglomerate, we are a small and steadily growing valuable consulting firm. -Valuable to our clients and consultants we work with. We have an excellent reputation with our clients and one that we continue to build upon. We are always looking for top talent.

*** EASY APPLY on our Company Page with RESUME ONLY (Cover page optional) ***

If this role is not a fit for you, and you're actively looking to be considered for work; please email us your resume: HireMe@VIEHIRE.com  

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