p>Required Skills: Analytical Chemistry, Analytical Chemistry, Analytical Method Development, Analytical Method Transfer, Biochemistry, Biologics, Chemical Engineering, Clinical Development, Clinical Microbiology, Cross-Functional Leadership, Documentations, Documentation Systems, End to End Process, Environmental Monitoring, Environmental Monitoring Systems, Ethical Compliance, GMP Compliance, GMP Guidelines, Innovation, Interpersonal Relationships, Microbiology, Molecular Microbiology, Molecular Structure, Pharmaceutical Management, Problem Solving {+ 7 more}.
The incumbent will be responsible for managing area status and GMP readiness, including oversight of equipment readiness and documentation systems; authoring, reviewing, and approving GMP documentation; reviewing and approving site and global SOPs (including oversight of the departmental SOP system); overseeing change management documentation, investigations, and corrective action plans; overseeing training plans and documentation; and facilitating and participating in on-site audits and inspections.