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Quality Associate Director

10+ years
Not Disclosed
10 April 9, 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 Associate Director

 Job ID:

R-206938

 Location:

India – Hyderabad

 Work Location Type:

On Site

 Date Posted:

March 19, 2025

 Category:

Quality


 About Amgen

Amgen is a global biotechnology leader focused on developing and delivering innovative therapies for serious illnesses in four core areas: Oncology, Inflammation, General Medicine, and Rare Disease. Since 1980, Amgen has been driven by its mission to serve patients and transform lives through science, collaboration, and cutting-edge innovation.


 Role Summary

As a Quality Associate Director, you will lead initiatives to integrate emerging technologies such as Artificial Intelligence (AI) into Quality systems, driving operational excellence and regulatory compliance. You will also play a key role in fostering a culture of quality, supporting Amgen’s global inspection readiness, and developing the next generation of quality leaders.


 Key Responsibilities

  • Develop and execute the Quality technology roadmap, focusing on AI and digital innovation

  • Align activities with GxP regulatory requirements and support Amgen’s mission

  • Partner with global and local teams to ensure inspection readiness and Quality service levels

  • Serve as the Quality point of contact for cross-functional digital and technology teams

  • Leverage AI to improve Quality systems, compliance, and efficiency

  • Attract, develop, and lead a high-performing digital technologies team

  • Champion diversity, leadership development, and mentorship

  • Deliver team goals aligned with corporate Quality strategy

  • Oversee budgeting and financial targets for the Quality team


 Basic Qualifications

One of the following educational paths AND required experience:

  • Doctorate degree with 3+ years of leadership in emerging Quality tech

  • Master’s degree with 10–14 years of leadership in emerging Quality tech

  • Bachelor’s degree with 14–16 years of leadership in emerging Quality tech

  • Diploma with 18–20 years of leadership in emerging Quality tech


 Preferred Qualifications

  • PhD, MS, or BS in Life Sciences, Engineering, or Computer Science/AI

  • 10+ years of leadership experience in the pharmaceutical industry

  • Expertise in AI, digital transformation, and Agile development

  • Proven ability to lead Quality transformation programs

  • Strong command of Quality Management Systems and GxP regulations

  • Excellent communication, critical thinking, and decision-making skills

  • Experience in mentoring, fostering diverse team culture, and change management


 Leadership Attributes at Amgen

  • Inspire: Foster inclusive and empowering environments

  • Accelerate: Drive swift progress for urgent patient needs

  • Integrate: Collaborate across teams for collective success

  • Adapt: Embrace change and lead with clarity


 What You Can Expect

  • Competitive base salary and benefits

  • A collaborative and inclusive work culture

  • Opportunities for personal and professional growth

  • A career that truly makes an impact on patient lives