Compliance, Training & Agreements Lead (AIN)

Lets do this. Lets change the world. Compliance, Training & Agreements is a function within GPS that leads and supports across all GPS functions: safety compliance activities, training, controlled documents, and process improvement activities. The team also oversees Inspection Readiness, PV & Device regulatory intelligence, GPS service provider business technical oversight, PV Agreements and project management activities including change management.

This position is a working manager focusing on activities around CAPAs, PV Regulatory Intelligence and Management reviews. The position also has a supervisory component overseeing and providing strategic, leadership and technical expertise to staff supporting activities around GPS Compliance Activities, Training/ On-boarding and PV agreements.

• Supervision of 1-10 staff in Amgen India with responsibilities supporting GPS CAPAs, PV Regulatory Intelligence process, Audit & Inspection Support, training, PV Agreements, Commercial Safety Liaisons and on-boarding and GPS Service Provider oversight and ensuring appropriate and consistent project management support is provided across GPS
• Leading direct reports on a day-to-day basis and escalating topics as needed to GPS Senior Leadership
• Proactively support compliance related and risk mitigation activities across GPS functions including due diligence activities as required
• Supports CAPA and deviation activities for GPS, including monitoring CAPA data and ensuring a robust Quality Management System
• Maintain and own the oversight of the Global PV Regulatory Intelligence process
• Support Management reviews and oversight of key compliance indicators
• Support Audit & Inspection readiness for GPS functions
• Support pre, peri and post activities around Health Authority Inspection and Internal Process Audits
• Support business technical oversight of all GPS Global Service Providers as required
• Support the Process Governance structure for GPS as required
• Support departmental best practices for the team in terms of project management and continuous improvement projects for GPS
• In a supervisory and direct capacity provide project support to process improvement initiatives for all departments within GPS
• Directly support Business Critical Projects as required
• Work cross-functionally to represent GPS in Projects
• Liaise with other cross-functional groups to ensure alignment of global safety plans with other functional plans
• Provide support and oversight for M&A Safety activities as required
• Identify and create communication and issue identification/ resolution plans as required
• Monitor and, as necessary, confirm data accuracy in safety systems for key deliverables
• Escalates issues / problems related to on-going projects to senior management in a timely manner and as needed
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Support PV Compliance Related activities as required
• Support benchmarking in relation to PV requirements
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by direct supervisor
• Management Responsibilities, as required
• Ensure staff are aligned with Amgen corporate and departmental training
• Provide training, coaching, mentoring, and development of staff
• Support staff as required
• Participating in and overseeing talent management strategies such as annual reviews, performance management, succession planning and employee development and retention.

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Masters degree and 8 to 10 years of directly related experience OR
• Bachelors degree and 10 to 14 years of directly related experience OR
• Diploma and 14 to 18 years of directly related experience
• Must have strong real-world Project Management skills
• Must have experience in PV environment with additional demonstrable experience in project management.
• Must have change control experience
• Must have strong leadership skills
• Must be able to comprehend pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions.
• Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills
• Works strategically to realize organizational goals
• Critical thinking and decision-making skills
• Exercise independent judgment
• Understanding business needs with global business perspective and professional attitude
• Demonstrate integrity
• Motivate and empower others
• Work productively in a high-pressure environment.
• Ability to identify proactively and anticipate risk of non-compliance in a complex environment
• Knowledge of business area and regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
• Able to manage both time and priority constraints and to manage multiple priorities simultaneously
• Attention to detail and computer literacy
• Take initiative and autonomous action
• Able to lead teleconferences and meetings
• Be able to manage conflict effectively

Preferred Qualifications:

PMP certification