Career Category
Supply Chain
Job Description
Job Summary
About Amgen
Amgen, a leading biotechnology firm since 1980, is committed to innovation and science, transforming discoveries into treatments for serious illnesses and continuously advancing its pipeline of potential new medicines to significantly improve lives.
Accountabilities
- Lead a team responsible for Trade Compliance and GDP Compliance activities supporting Amgen’s supply chain organization.
- Provide leadership, direction, coaching, and development to a team of compliance professionals, fostering a culture of accountability, collaboration, and CI.
- Ensure effective execution of Compliance activities through appropriate oversight, prioritization, governance, and resource management.
- Drive OE through standardized processes, performance management, risk mitigation, and CI initiatives.
- Ensure compliance processes, controls, procedures, and monitoring activities meet regulatory requirements and Amgen standards.
- Partner with cross-functional stakeholders to ensure compliant operations, effective issue resolution, and successful implementation of business and compliance initiatives.
- Support organizational readiness for audits, inspections, and regulatory requirements.
Position Specific Tasks
Management Responsibilities
- Responsible for hiring, training, supervising, coaching, and performance management of staff.
- Establish team priorities and allocate resources to support business objectives and requirements.
- Provide leadership and direction, ensuring timely execution and resolution of operational and compliance-related issues.
- Review performance, identify risks and improvement opportunities, and drive actions as needed.
- Develop team capabilities and support a high-performing, customer-focused organization.
Trade Compliance Oversight
- Provide oversight of operational Trade Compliance activities supporting global import and export requirements.
- Ensure effective controls, procedures, training, and monitoring activities are maintained to support compliance with applicable trade regulations and Amgen policies.
- Oversee metrics, performance monitoring, and CI initiatives.
- Support customs audits, inspections, regulatory inquiries, and management of third-party service providers.
- Partner with Global Trade Compliance, Legal, Customs Brokers, and business stakeholders to support compliant execution and risk management.
GDP Compliance Oversight
- Provide oversight of GDP, FMD, and quality system compliance activities supporting global distribution operations.
- Ensure effective management of deviations, investigations, CAPAs, temperature excursions, distribution complaints, and related quality records.
- Oversee compliance documentation, training, process governance, and inspection readiness activities.
- Support implementation of new capabilities, systems, and business processes impacting supply chain compliance.
- Drive continuous improvement initiatives to enhance compliance performance, process effectiveness, and operational efficiency.
Authority
- Direct management and development of staff.
- Works under minimal direction with responsibility for operational and project objectives.
- Independently determines approach to manage projects, compliance operations, and team priorities.
- Makes decisions regarding resource allocation, prioritization, escalation, and implementation of process improvements.
- Participates in department goal setting and policy development activities.
Outputs
- Effective leadership and development of a high-performing team.
- Efficient and compliant execution of Compliance activities.
- Timely resolution and closure of compliance and quality records.
- Successful support of audits, inspections, and regulatory requirements.
- Compliance performance metrics, reporting, and governance activities.
- Standardized processes and sustainable continuous improvement outcomes.
- Strong stakeholder partnerships and effective issue resolution.
Skills and Qualities
Basic Qualifications
9-13 Years of relevant experience.
Preferred Qualifications
- Experience leading teams within Supply Chain, Compliance, Quality, Trade Compliance, or related functions.
- Experience within pharmaceutical, biotechnology, healthcare, or other highly regulated industries.
- Knowledge of international trade regulations, GDP, FMD, and quality management systems.
- Experience supporting audits, inspections, and compliance programs.
- Demonstrated ability to lead cross-functional initiatives and drive organizational change.
Competencies
- Proven people leadership and team development capabilities.
- Ability to establish priorities, allocate resources, and deliver results through others.
- Strong risk-based decision-making and problem-solving skills.
- Effective communication, influencing, and stakeholder management skills.
- Ability to build strong partnerships across functions, regions, and organizational levels.
- CI mindset with focus on OE.
- Ability to navigate ambiguity, manage competing priorities, and lead through change.
- Strong analytical skills and business judgment.
- High degree of accountability, integrity, and attention to detail.
.