Gcp Compliance Mgr

**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**
- 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

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.