Safety and Medical Quality lead-Observational Research

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Safety and Medical Quality Lead - Observational Research

What you will do

Let’s do this! Let’s change the world! The Safety and Medical Quality team is a diverse international team within the Global R&D Quality organization. We are responsible for strengthening and enhancing the R&D Quality Management System, providing Quality oversight on R&D processes and leading activities related to PV regulatory inspections and external audits of the Amgen PV system.

The Quality Lead role in the Safety & Medical Quality organization will support proactive identification of compliance issues relating to processes and programs, and escalation to compliance and quality oversight bodies, and participate in quality investigations, management and remediation.

This role will support Safety and Medical processes with a focus on Observational research activities. The role will be responsible for supporting processes and activities related to the pharmacovigilance (GPvP) annual audit plan, the preparation and execution of audits, the investigation and monitoring of Quality events and supporting partner audits and regulatory inspections.

Primary Responsibilities

• Plan, conduct and report on risk-based R&D audits

• Support the execution of the audit plan for GPvP suppliers/vendors and processes.

• Support investigations of deviations from GPvP and GCP processes including execution 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 audits from business partners. GxP inspection readiness and inspection management activities.

• Support R&D Quality governance bodies in the clinical development, pharmacovigilance and/or observational research areas.

• Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews

• Maintain knowledge of current regulatory and quality practices/issues

• Collate compliance metrics (e.g. audit/inspection data and other significant compliance information) to support presentations to key partners.

• Support vendor evaluations related to observational research studies and GPvP or GCP vendors

• 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).

Key Competency

• Verbal and Written Communication

• Teamwork

• Time Management

• Interpersonal Skills

• Analytical Skills

• Problem Identification and Resolution

• Ability to identify and implement process improvements

• Diversity Awareness

• Conflict Management

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 3 years of quality experience OR

• Bachelor’s degree and 5 years of quality experience OR

• Associate’s degree and 10 years of quality experience OR

• High school diploma / GED and 12 years of quality experience

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