Quality Compliance Manager, Safety & Medical Quality

at  Amgen

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

BASIC QUALIFICATIONS:

Doctorate degree
OR
Master’s degree and 2 years of R&D, Operations and/or Quality experience
OR
Bachelor’s degree and 4 years of R&D, Operations and/or Quality experience
OR
Associate’s degree and 8 years of R&D, Operations and/or Quality experience
OR
High school diploma / GED and 10 years of R&D, Operations and/or Quality experience

PREFERRED QUALIFICATIONS:

• Experience as an auditor, preferably in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)
• Verbal and Written Communication
• Teamwork
• Time Management
• Interpersonal Skills
• Analytical Skills
• Problem Identification and Resolution
• Diversity Awareness
• Conflict Management

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this vital role you will support proactive identification, customer concern to appropriate compliance/quality oversight bodies and participate in quality investigations and management and remediation of compliance issues relating to processes, programs, and external relationships. This role will support Safety and Medical processes including but not limited to the requirements for Patient Support Programs, Market Research, Digital sites, Social Media and Business Partners. The role will be responsible for supporting processes and activities related to the annual audit plan, the investigation and monitoring of self-reported deviations and the preparation and follow through of audits and inspections.

RESPONSIBILITIES:

• Support the audit plan for PV suppliers/vendors and processes.
• Support investigations of deviations from GPvP processes including follow through of root cause analysis, design, development or Corrective and Preventive Actions (CAPAs) and Effectiveness Verifications (EVs).
• Entering and updating records in the digital quality management system (DQMS) based on investigation and deviation meetings and tracking through to closure.
• Collating and verifying objective evidence for inspection & audit driven CAPAs/EVs.
• Data entry into the risk assessment tool (using risk assessment methodology)
• Support Safety and Global Development teams in GxP inspection readiness and inspection management activities.
• Support Safety and Global Development teams in GxP audits from business partners.
• Support R&D Quality governance bodies in the clinical development, pharmacovigilance and/or research area.
• Maintain knowledge of current regulatory and quality practices/issues
• Collate compliance metrics (e.g. audit/inspection data and other compliance information) to support presentations to key collaborators.
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods).