Job Description
The Global Quality Manager (GQM) is considered to be a position of increased responsibility within the Global Clinical Quality function. He or she will be responsible for the GCP and/or GVP auditing internal and external entities
In addition, he or she will represent GCQ as a quality engagement member of a Study Team and/or Otsuka and Global Quality initiatives.
The Global Quality Manager may also support Quality operations within the larger Global Quality Management group. He or she would be responsible for driving the management of assigned activities within the group. This could include SOP Management, CAPA Management, Deviation Management, SOP/GxP related Training and Inspection Readiness and support in addition to other assigned Quality tasks.
Key Responsibilities:
The Global Quality Manager may manage contingent worker(s) (indirect reports) who are responsible for all activities within the GCQ team. He or she would be responsible for independently preparing for conducting and authoring audit/assessment reports for global clinical Trial Master Files and Pharmacovigilance System Master files.
He or she may be asked to support routine and directed clinical investigator site audits, External Service Provider and CRO audits, internal clinical/PV process audits both domestic and international as assigned. He or she would also independently or within a committee review and determine acceptability of CAPAs. He or she would also be responsible for managing Inspection Readiness activities and regulatory authority inspection and/or external audit support.
He or she would be working with GCQ colleagues, assists in the follow-up and escalation process for Corrective Actions Preventive Actions (CAPA) identified via the audit process, as well as act as a GCQ Audit and Engagement Representative to one or more Otsuka business functions and/or project teams such as CM, GCD, DM and Stats.
He or she will drive the optimization and/or execution of assigned GQM operational responsibilities, prepare and deliver internal and external presentations (as assigned), independently provide GCP guidance and shares expertise in the interpretation of clinical development regulations and Good Clinical Practice (GCP) guidelines, properly escalate issues and risks to the Otsuka business to GQM Leadership, and perform activities that support overall departmental goals and objectives.
Qualifications
Knowledge:
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