Job Title: Compliance, Training & Agreements Lead
Location: Hyderabad, India
Work Location Type: On-site
Date Posted: January 7, 2025
Category: Safety
Job Summary:
Amgen is seeking a Compliance, Training & Agreements Lead within the Global Patient Safety (GPS) function. This role will support a wide range of activities related to safety compliance, training, process improvement, and oversight of Pharmacovigilance (PV) Agreements. As a working manager, the individual will supervise a team, oversee CAPA (Corrective and Preventive Actions), PV Regulatory Intelligence, and ensure alignment with regulatory standards and project management best practices.
Key Responsibilities:
Supervision and Leadership:
Supervise a team of 1-10 staff in Amgen India supporting GPS activities.
Lead day-to-day activities and escalate issues to senior leadership when necessary.
Provide strategic leadership and technical expertise to staff supporting CAPA, PV Regulatory Intelligence, Audit & Inspection Support, PV Agreements, and Service Provider Oversight.
Compliance & Risk Mitigation:
Proactively support compliance-related and risk mitigation activities across GPS functions.
Monitor CAPA data and ensure robust Quality Management Systems.
Lead the Global PV Regulatory Intelligence process and ensure it is aligned with global safety plans.
Support Health Authority Inspections and Internal Process Audits, ensuring inspection readiness at all times.
Project and Process Management:
Support business-critical projects and process improvement initiatives across departments within GPS.
Oversee Process Governance and help develop best practices for project management and continuous improvement within GPS.
Ensure effective project management support is provided across GPS functions, including change management and due diligence activities.
Training and Development:
Ensure team alignment with Amgen’s corporate and departmental training programs.
Provide training, coaching, and mentoring to staff, overseeing talent management strategies such as performance reviews, succession planning, and employee development.
Global Collaboration:
Liaise with cross-functional teams and global business partners to ensure alignment and support of safety plans and projects.
Support M&A Safety Activities as required and manage data accuracy in safety systems for key deliverables.
Management and Reporting:
Oversee the management of CAPAs, deviations, and ensure the organization is compliant with all safety requirements.
Escalate issues to senior management in a timely manner when necessary.
What We Expect from You:
Basic Qualifications:
Master’s degree and 8 to 10 years of directly related experience OR
Bachelor’s degree and 10 to 14 years of directly related experience OR
Diploma and 14 to 18 years of directly related experience
Project Management experience with expertise in PV and change control.
Strong leadership, critical thinking, and decision-making skills.
Regulatory compliance knowledge, particularly within pharmacovigilance.
Ability to work independently and manage multiple priorities.
Strong interpersonal, conflict management, and team leadership skills.
Proven ability to work in an international environment and manage global projects.
Preferred Qualifications:
PMP (Project Management Professional) Certification is highly preferred.
What Amgen Offers:
Amgen provides a competitive and comprehensive Total Rewards Plan, which is aligned with local industry standards. The company also supports both your professional and personal growth, offering an inclusive and collaborative culture.
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