Career Category

Job Description

Accountability

• To support objective compliance advice and oversight to the business for GCP activities
• Strengthen and advance Amgen’s R&D QMS
• Improve R&D processes through contribution of expertise in identifying appropriate CAPAs
• Enable timely completion of CAPAs through CAPA status reports
• Identify CAPA trends
• Ensure quality of data in RDCS (R&D CAPA System)

Responsibilities
The role of the GCP Compliance Manager is to support the provision of proactive GCP compliance oversight and guidance to functional areas and stakeholder groups within the R&D organization. Activities are to be performed under supervision of Compliance Senior Manager and/or Director GCP Compliance.

This includes:

• Entering and updating records in RDCS based on investigation and exception meetings and tracking through to closure
• Supporting investigation lead in RCA & effectiveness verification activities of CAPAs
• Collating and verifying objective evidence for inspection & audit-driven CAPAs
• Assessing quality and accuracy of data in RDCS and reporting on RDCS status, progress and activities, as required based on regulations and guidance from the manager
• Data entry into the risk assessment tool (using risk assessment methodology)
• Support Safety, Global Development and Global Research teams in GCP inspection readiness and inspection management activities
• Support R&D Compliance on governance bodies in the clinical development, pharmacovigilance and/or research area
• Support the GCP compliance team as needed with functional activities including exception management, inspection readiness, administration of compliance committees
• Maintain knowledge of current regulatory and compliance practices/issues
• Collate compliance metrics (e.g. audit/inspection data and other significant compliance information) to support presentations to key stakeholders

Basic Qualifications

Qualifications

• Bachelor’s degree in appropriate discipline (required) or equivalent (e.g., Nursing qualification)

Experience

• Minimum 4 years in biopharmaceutical industry
• Minimum 2 years in GCP compliance
• Experience in exception management (include RCA) in a GCP setting
• Experience supporting regulatory authority inspections of GCP (e.g. clinical research, pharmacovigilance) activities
• Participation in process improvement initiatives

Knowledge

• Knowledge of global GCP regulations
• Knowledge of regulatory authority inspection processes
• General knowledge GCP processes and operations in the bio-pharmaceutical industry
• Understanding of audit/compliance program design

Preferred Qualifications

• GCP Quality Assurance Qualification / Certification

Knowledge

• Familiarity with advanced concepts of clinical research
• Extensive knowledge of ICH/GCP regulations and guidelines
• Strong knowledge of clinical trial operations
• Understanding of Functional Service Provider operational model
• Computer and system operation skills
• Relevant therapeutic area education and training
• Detailed understanding of customer service
• Demonstrated ability to anticipate and resolve problems

Competencies

• Disciplinary knowledge; leverages business acumen and subject matter expertise
• Understanding of company goals and competitor practices
• Understanding of company business priorities, strategy and direction
• Knowledge of areas addressed by the GCP Compliance function
• Knowledge of R&D function and business principles
• Applies analytical skills to evaluate and interpret compliance situations (and viable solutions) using multiple sources of information, including qualitative, quantitative and trend data
• Manages multiple assignments