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Safety and Medical Quality lead-Observational Research

US - California - Thousand Oaks - Field/Remote

Career Category

Quality

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 …

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Job Profile

Regions

North America

Countries

United States

Restrictions

Field/Remote Hybrid

Benefits/Perks

Annual bonus program Career development Career development opportunities Career transformation Collaborative culture Competitive benefits Comprehensive employee benefits Comprehensive employee benefits package Discretionary annual bonus Financial plans Flexible Spending Accounts Flexible work models Health and welfare plans Hybrid work Innovative environment Life and Disability insurance Personal growth Professional and personal growth Retirement and Savings Plan Stock-based long-term incentives Time-off plans Total Rewards Plan Welfare plans

Tasks
  • Communication
  • Conduct audits
  • Implement process improvements
Skills

AI Analysis Analytical Analytics Auditing Biopharmaceutical Biopharmaceutical Industry BioTech Clinical Development Communication Compliance Data analysis Data Entry Development Execution GCP Governance GxP Inflammation Inspection Readiness Insurance Interpersonal Leadership Management Natural Language Processing Observational Research Oncology Operations Organization People Pharmacovigilance Programming Quality Quality Management Quality Management System R Rare Disease R&D Regulatory Compliance Research Risk Assessment Root Cause Analysis Safety Sales SAS STATA Statistical Programming Teams Teamwork Therapeutic Areas Time Management Written communication

Experience

5 years

Education

Associate Degree DO Doctorate Doctorate degree GED High School High school diploma

Timezones

America/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9