Senior Manager, GPV Compliance & Business Management (CBM)

Job Summary
The Senior Manager, GPV Compliance & Business Management will support the leads of Global PV Audit & Inspection readiness (AIR) activities and Global PV Corrective Action Preventative Action (CAPA) and Deviation for the processes managing and maintaining compliance. This role will work collaboratively with other stakeholders from Global Pharmacovigilance (GVP) groups, Affiliate PV Coordination Group (APVC), Global Quality Management (GQM), the Global QPPV Office and Regional Pharmacovigilance Heads as required to ensure compliance across the GPV organization. As required, this colleague will work with other CBM leads to align on the other activities cross the sub-functions within CBM, such as compliance, PV SOPs, etc.

Job Description
• Provide support to the GPV Audit & Inspection Readiness Lead for the management and oversight of PV related audits and inspections, including but not limited to the planning and conducting readiness activities/training.
• As the Sr. Manager for audits and inspection, support the GPV Audit & Inspection Readiness Lead for audits and inspections by providing support and guidance to SMEs, including management of backroom and front room.
• Work with APVC and Global Quality to provide support to local affiliates for preparation and expectations of audits.
• Work with Global Quality, Head of CBM, and the Global QPPV to confirm Company Main Contact (CMC) details for audits.
• Support the GPV Audit & Inspection Readiness Lead on QC of documents to be shared for Audits/inspections.
• Participate in regular meetings with Global Quality for alignment as required.
• Support the Global PV CAPA & Deviation lead in the management of PV related Audit Finding Responses and, in the development, and execution of corrective actions/preventative actions (CAPA) plans.
• Development, management and tracking of CAPAs relevant to PV, evaluation/review of PV Audit/Inspection findings, as required.
• Collaborate with Otsuka departments/teams internal and external to provide oversight and ensure proper development of CAPAs from internal quality audits and support regulatory inspections as needed.

​​Provide guidance and support for CAPA implementation and documentation.

• Facilitate discussions with CAPA owners to drive completion of investigations, root-cause analysis, impact analysis, and closure of CAPA.
• Support the Global PV CAPA & Deviation lead to devel