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Quality Manager III
Ref No.: 19-05078
Location: Swiftwater, Pennsylvania
We are searching for an experienced individual to join a team working as a Quality Manager III !!!!!

Our client is a global biopharmaceutical company committed to healthcare solutions from prevention to treatment.  they turn scientific discoveries into medicine to improve human health.  Everyday they dedicate their most important resource, the people, to support patients and families through their health journey.


Job Description:
The Quality Manager III 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. 

Job Requirements:
  • 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 sch as Validation Planning, Biotech Process.
  • Validation, Equipment and Facility Qualification and Validation Risk Management.
  • signatory responsibilities for validation/qualification documents within assigned areas.

Education/Experience:
  • 5+ years' experience in a GMP regulated environment working on validation projects associated with biotech es and equipment
  • 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
  • The ability to work on cross functional project teams
  • Meet/Exceed project timelines/deliverables
  • Experience with Quality systems including: SAP, Quality eDoc, LabWare, TrackWise, Delta V, 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
Languages:
English (Speak, Read, Write )