Tunnell Consulting Inc. Quality Manager - V in Framingham, Massachusetts

Quality Manager - V

Job City: Framingham

Job State: US - Massachusetts

Client Project Number: 9137


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.

Skills: 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

*The 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



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

Required Skills: