Job Title: GPS Compliance & Training Manager
Location: Hyderabad, India
Work Location Type: On-site
Date Posted: February 4, 2025
Category: Safety
Job Summary:
As a GPS Compliance & Training Manager at Amgen, you will provide crucial support for pre-, peri-, and post-audits and inspections, with a proactive focus on Inspection Readiness activities. You will also play a key role in supporting GPS's Quality Management System, managing service provider oversight, and collaborating on compliance activities, training, and document management across GPS.
Key Responsibilities:
Inspection Readiness & Compliance:
Support the proactive GPS Inspection Readiness program, ensuring the team is prepared for Health Authority Inspections and internal audits.
Lead compliance activities for high-risk processes within GPS.
Work closely with GPS Business Process Owners (BPOs) and service providers to manage and resolve compliance concerns, including CAPAs and audit/inspection findings.
Service Provider & Project Oversight:
Provide oversight and mitigation support for compliance concerns related to GPS Service Providers.
Assist with project management support across GPS departments and ensure timely escalation of issues to senior management.
Support M&A Safety activities and monitor safety system data accuracy for key deliverables.
Regulatory Compliance & Reporting:
Undertake activities delegated by the QPPV (Qualified Person for Pharmacovigilance) as outlined in the PV System Master File and maintain inspection readiness.
Support Global PV Regulatory Intelligence and assist in maintaining SharePoint sites and relevant systems.
Contribute to training and controlled document maintenance across GPS and assist with on-boarding and Job Description (JD)/CV maintenance as needed.
Qualifications:
Basic Qualifications:
Doctorate degree OR
Master’s degree or PMP certification plus 4 years of relevant experience OR
Bachelor’s degree & 7 years of directly related experience OR
Associate’s degree & 10 years of directly related experience OR
High school diploma / GED & 12 years of directly related experience.
Preferred Qualifications:
Strong understanding of Regulatory and Safety functions.
Experience in Pharmacovigilance Audits and Inspections.
Knowledge of Vendor Oversight.
Skilled in Project Management, particularly in matrix environments.
Experience in Safety Audit and Inspection activities.
Proficient in Managing diversity and building effective teams.
Strong execution skills in overseeing multiple projects.
Gujarat :
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