Local: Supervise a team of Quality Operations specialists to maintain the Quality systems that are in place for Site Operations in accordance to AbbVie Policies and cGMP. Supports the development and implementation of Quality systems for Site Operations in accordance to AbbVie Policies and cGMP. SME for 3-4 cGMP, QO systems. Puts a system in place that ensures team support of routine business operations support 24/7. Provide quality oversight for Warehouse, QC, Manufacturing, Engineering (facilities) and IT. Responsible for change management and batch record review and release. Ensure high quality execution and NPI has no impact to routine operations.
Global: Participates in Quality COE. Works with global counterparts to ensure cross-site Operations remain compliant with AbbVie Policies and cGMP
OE: Participates in cross functional team to achieve site objectives. Promotes initiatives to streamline Quality systems. Coaches Specialists on cGMP and QO systems. Supervises Specialists to achieve site goals / metrics. Mentors Interns and Associates to assimilate into the Quality Culture
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Review and approve SOPs of stakeholders (local) independently
Bachelor's degree in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or related Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent
Review and approve SOPs of stakeholders (local) independently
BachelorÃÂâÃÂÃÂÃÂÃÂs degree in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or related Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent