Sr. Manager, GCP/GVP

Shionogi Inc.•Florham Park, NJ

5d•$135,000 - $165,000•Hybrid

About The Position

This role will support and maintain a robust GVP and GCP compliance program across the organization, with GVP QA as the primary responsibility and GCP QA as the secondary responsibility. This role will collaborate with the Global GVP/GCP QA teams to provide quality oversight of pharmacovigilance (PV), business/licensing partners, distributors, clinical studies, CROs/vendors, ensuring regulatory compliance with FDA, EMA, PMDA, MHRA, ICH, additional local requirements as applicable, and other global guidelines.

Requirements

BA/BS in life sciences, a scientific, technical discipline, or a related field.
Minimum of 6 years of experience in a GVP/GCP QA/quality/compliance role or regulatory inspectorate role supporting PV and/or clinical study teams.
Working knowledge of GVP/GCP regulations and guidelines, including ICH, FDA, EMA, MHRA and PMDA requirements.
Strong attention to detail, team player, agile, excellent communication skills, strong critical thinking skills, and effective problem-solving abilities.
Excellent project management, organizational, and leadership skills to manage cross-functional teams and multiple projects simultaneously.
Capable of operating in an ambiguous environment.
Capable of operating independently with a leveled understanding of decision making.
Ability and willingness to travel up to 15% of the year both domestically and internationally.
Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Hybrid office presence is required at 50% of the time per month.

Responsibilities

Engage in the development, implementation, and maintenance of the GVP and GCP Quality Management System (QMS), ensuring compliance with worldwide and local PV regulations.
Actively engage in preparedness for the regulatory inspections, e.g., FDA PADE inspection. Collaborate with the Global QA teams in the development and execution of audit strategies, manage, oversee or conduct audits.
Ensure ongoing compliance with relevant GVP and GCP global and local regulatory requirements and guidelines, including management and support in maintenance of Pharmacovigilance System Master Files (PSMF).
Manage compliance with risk assessments, facilitate root cause analysis, and ensure the implementation and effectiveness of Corrective and Preventive Actions (CAPAs) and effectiveness checks.
Act as a primary GVP Quality contact of all GVP related matters and GCP Quality contact as assigned, collaborating with cross-functional teams and internal departments.
Drive the continuous improvement of GVP and GCP quality systems and procedures.
Other duties as assigned.