Instagram
youtube
Facebook

Quality Compliance Manager, Safety & Medical Quality

2-10 years
Not Disclosed
10 Feb. 5, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Compliance Manager, Safety & Medical Quality
Location: US - California - Thousand Oaks
Category: Compliance
Job ID: R-198877
Work Location Type: On Site
Salary Range: 107,900.00 USD - 129,382.00 USD


About Amgen

Amgen is one of the world’s leading biotechnology companies, focused on serving patients through groundbreaking scientific advancements. Since its founding in 1980, Amgen has reached over 10 million patients worldwide, pioneering treatments for some of the toughest diseases. With a commitment to excellence and innovation, Amgen fosters a collaborative and inclusive environment for professionals looking to make a difference in the world of healthcare.


Key Responsibilities

  • Audit & Compliance Oversight: Support the audit plan for pharmacovigilance suppliers and vendors. Participate in quality investigations, root cause analysis, and CAPA (Corrective and Preventive Actions).
  • Risk Management & Data Entry: Enter and update records in the Digital Quality Management System (DQMS), ensuring accurate tracking of investigation outcomes and CAPA effectiveness.
  • Inspection & Audit Support: Assist in GxP inspection readiness and manage inspection activities, including support for audits from business partners and internal teams.
  • Regulatory & Quality Practices: Maintain knowledge of current regulatory practices and issues, ensuring alignment with industry standards.
  • Innovative Quality Oversight: Implement innovative methodologies for quality oversight, including the use of AI, Natural Language Processing, and advanced data analytics.
  • Metrics & Reporting: Collect and analyze compliance metrics to support presentations and ensure quality oversight is transparent and effective.

Qualifications

  • Basic Qualifications:
    • Doctorate degree OR
    • Master’s degree with 2 years of R&D, Operations, or Quality experience OR
    • Bachelor’s degree with 4 years of R&D, Operations, or Quality experience OR
    • Associate’s degree with 8 years of R&D, Operations, or Quality experience OR
    • High school diploma/GED with 10 years of R&D, Operations, or Quality experience.
  • Preferred Qualifications:
    • Experience as an auditor (preferably in GCP, GLP, or GPvP).
    • Strong verbal and written communication skills, teamwork, time management, interpersonal and analytical skills.
    • Expertise in problem identification and resolution, as well as conflict management.

What You Can Expect

  • Salary & Benefits: Amgen offers a competitive salary and total rewards package, including healthcare, retirement plans, and stock-based incentives.
  • Work-Life Balance: Enjoy flexible work models, including remote arrangements when possible, and generous time-off plans.
  • Career Development: Access career growth opportunities, mentorship, and a culture of innovation to develop professionally and personally.