Quality Manager V
Company: PSG Global Solutions Careers
Posted on: September 11, 2023
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We're looking for a Quality Manager V, working in Pharmaceuticals
and Medical Products industry in 31 New York Avenue, Framingham,
Massachusetts, 01701, United States.
- 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
- Signatory responsibilities for validation/qualification
documents within assigned areas.
Our client is an award-winning clinical development company.
Improving lives globally with 20+ years experience in clinical
research and strategic resourcing. Elevating results with proven
strategies, comprehensive solutions, and customized delivery
Serving pharmaceutical, biopharmaceutical, biotechnology, and
medical device organizations.
Strong relationships provide you connections and access to great
opportunities. Industry expertise sets you up for success with
helpful insights, career coaching, and professional training. Grow
and learn while you put your skills to work.
Experience Required for Your Success
- 5+ years experience in a GMP regulated environment working on
validation projects associated with biotech processes and
- 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
- Knowledge of vaccines/biologics products and associated
- 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.
What Do You Think?
Does your experience reflect what it takes to be successful in this
role? Do the work and challenges get you excited about what's
Keywords: PSG Global Solutions Careers, Framingham , Quality Manager V, Executive , Framingham, Massachusetts
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