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Commercial Programs Quality Oversight- Remote

3-14 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: Commercial Programs Quality Oversight and Monitoring Lead
Location: United States - Remote
Category: Manufacturing
Job ID: R-204683
Work Location Type: Remote


About Amgen

Amgen is a leader in biotechnology, focused on transforming the lives of patients through innovative treatments for serious diseases. With expertise in Oncology, Inflammation, General Medicine, and Rare Disease, Amgen reaches millions of patients globally. The company's collaborative, innovative, and science-based culture is dedicated to making a lasting impact on patient care. If you're passionate about overcoming challenges and impacting the future of healthcare, Amgen invites you to join their team.


Key Responsibilities

  • Quality Oversight: Provide oversight for Patient Support Programs, Market Research, Digital Health, Websites, and Social Media, ensuring compliance and addressing any quality issues.
  • Audit Management: Lead audits for Patient Support Programs, Market Research, Digital Health, Websites, and Social Media, managing vendor oversight and inspection preparation.
  • Compliance & Risk Management: Advise stakeholders on Pharmacovigilance programs, mitigate compliance risks, and handle significant quality issues.
  • Team Leadership: Lead a team of 2-4 professionals, overseeing their development and performance.
  • Strategy & Execution: Implement proactive quality management, including vendor oversight, CAPA management, and emerging regulatory trend analysis.
  • Cross-Functional Collaboration: Partner with senior leaders in Commercial, Regulatory Affairs, and Medical teams to resolve quality and compliance issues and drive improvements.
  • Process Development: Contribute to the implementation of Amgen's new Quality management system and lead the deviations process.

Qualifications

  • Basic Qualifications:
    • Doctorate degree with 3 years of R&D, Operations, and/or Quality experience in the PhRMA/Biotech sector OR
    • Master’s degree with 7 years of R&D, Operations, and/or Quality experience OR
    • Bachelor’s degree with 9 years of R&D, Operations, and/or Quality experience OR
    • Associate’s degree with 12 years of R&D, Operations, and/or Quality experience OR
    • High school diploma/GED with 14 years of experience in the PhRMA/Biotech sector.
    • At least 3 years of experience directly managing people or leading teams, projects, or programs.
  • Preferred Qualifications:
    • Proven experience in GPvP Quality Management and managing cross-functional teams.
    • Strong understanding of regulatory environments affecting PhRMA/Biotech.
    • Expertise in leading impactful teams and fostering creativity and innovation.
    • Exceptional communication and negotiation skills.

What You Can Expect

  • Salary & Benefits: Competitive salary with a comprehensive benefits package.
  • Work-Life Balance: Flexible work models, including remote and hybrid work options.
  • Career Development: Opportunities for growth within a collaborative environment that values personal and professional development.