Career Category

Job Description

Accountabilities
 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

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