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Product Quality Associate Director

8+ years
Not Disclosed
10 Dec. 14, 2024
Job Description
Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD 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

Here’s a refined and concise version of the Product Quality Associate Director job description for Amgen:


Position: Product Quality Associate Director

Department: Product Quality (PQ)
Location: Amgen India Location (AIN)


About Amgen

At Amgen, our mission is to serve patients living with serious illnesses. For over 40 years, we’ve been at the forefront of biotechnology, delivering innovative medicines that improve lives. Focused on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—our work impacts millions of people each year.

As part of our award-winning culture, you’ll join a team that values collaboration, innovation, and science-based approaches. Transform lives while building a fulfilling career at Amgen.


Role Overview

As Product Quality Associate Director, you will lead the Product Quality team at Amgen India and provide cross-functional leadership to support late-stage and commercial biologics and synthetic products. You’ll ensure alignment with Product Quality goals, regulatory compliance, and GMP standards.

This role includes direct management of the Product Quality team, responsibility for deliverables, and support for critical initiatives such as stability programs, regulatory filings, and comparability assessments.


Key Responsibilities

Leadership and Team Management:

  • Lead a cross-functional team to ensure seamless delivery of Product Quality (PQ) objectives.
  • Provide strategic direction and manage resources for PQ activities.

Product Quality Support:

  • Support late-stage/commercial biologic or synthetic programs, including PQT actions, APRs, specifications, comparability, and stability programs.
  • Collaborate with global teams to author/review GMP and regulatory documents.
  • Execute and manage tasks in GMP systems, including document management, data analysis, and complaint resolution.

Data Analysis and Regulatory Compliance:

  • Conduct science- and risk-based evaluations of process and product data (e.g., in-process, release, stability data).
  • Ensure adherence to cGMP and international regulatory expectations.
  • Provide expert guidance during regulatory submissions and inspections.

Qualifications

Basic Qualifications:

  • Doctorate in chemistry, biochemistry, biology, or related field + 3 years of relevant experience, OR
  • Master’s in a related field + 6 years of relevant experience, OR
  • Bachelor’s in a related field + 8 years of experience, including 3 years in a managerial or leadership role.

Preferred Qualifications:

  • Experience working virtually on cross-functional teams across time zones.
  • Expertise in GMP systems (e.g., Veeva, Spotfire, SHINY).
  • Advanced proficiency in MS Office tools (Word, Excel, PowerPoint, MS Teams).

Skills & Competencies

Technical Skills:

  • Strong knowledge of cGMP, regulatory standards, and scientific data management.
  • Proficiency in computer-based GMP quality systems.

Soft Skills:

  • Exceptional leadership, analytical, and problem-solving capabilities.
  • Ability to manage multiple priorities, react swiftly to urgent requests, and meet tight deadlines.
  • Excellent written/verbal communication and presentation skills.

Why Join Amgen?

What We Offer:

  • Opportunities for growth in a diverse and inclusive environment.
  • Competitive salary and a comprehensive Total Rewards Plan that includes health, career, and work-life benefits.

Impactful Work:

  • Directly contribute to transformative therapies that improve patient outcomes.

Equal Opportunity Statement

Amgen is an Equal Opportunity Employer committed to fostering diversity and inclusion. We provide reasonable accommodations to individuals with disabilities to ensure their participation in the hiring process, performance of essential job functions, and access to employment benefits.


Ready to Transform Lives?

Apply now and embark on a career that defies imagination.

Visit careers.amgen.com


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