Sr Associate Product Quality - Analytical

Amgen Inc. (IR); Hyderabad; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Amgen seeks an experienced quality professional to support late-stage clinical and commercial products. You will act as a primary author for GMP regulatory reports, manage GMP data in compliant systems, and ensure accuracy across submissions.

This role requires strong GMP knowledge, technical writing expertise, and cross-functional collaboration across global teams to meet tight timelines and maintain data integrity. Training and mentorship may be part of the role.

Qualifications

• Master’s degree with minimum 6 years of experience in Quality, Operations, Scientific, or Manufacturing fields.
• Strong understanding of GMP requirements, US FDA, and ICH regulations.
• Experience in technical writing for GMP/regulatory submissions.
• Experience supporting cross-functional teams in global environments.

Responsibilities

• Navigate and manage GMP data in compliant systems (Empower, LIMS, Veeva, Spotfire).
• Author and maintain GMP technical reports supporting regulatory filings within quality systems (e.g., Veeva).
• Collate, review, verify, and archive GMP data for late-stage clinical and commercial products.
• Collaborate across global teams and time zones, communicating findings and updates clearly.
• Ensure accuracy and completeness of product data with attention to detail.

Skills

GMP compliance

Technical writing

Cross-functional collaboration

Analytical skills

Communication skills

MS Office proficiency

Education

Master’s degree in Pharmaceutical/Biotechnology

Tools

Veeva

Empower

LIMS

Spotfire

Job description

Career Category Quality Job Description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description: This role is an individual contributor role that provides critical support to Product Quality Teams (PQTs) for late-stage clinical and commercial products. In this role, you will serve as a primary author of technical and regulatory reports, manage GMP data within compliant systems, and help ensure accuracy, completeness, and compliance across global submissions. You will also play an integral role in maintaining Amgen’s electronic databases and mapping tools, supporting continuous improvement initiatives, and providing peer training as needed. This role requires strong expertise in GMP compliance, technical writing, and cross-functional collaboration to drive high-quality outcomes under tight timelines.

Roles & Responsibilities:

• Navigate and execute transactions in GMP systems (Empower, LIMS, Veeva, Spotfire).
• Work closely with in the product Quality organization to drive standardization of data, and chromatographic overlay activities.
• Author and maintain GMP technical reports supporting regulatory filings within quality systems (e.g., Veeva).
• Collate, review, verify, and archive GMP data for late-stage clinical and commercial products.
• Ensure accuracy and completeness of product data with high attention to detail.
• Collaborate across global teams and time zones, effectively communicating findings and project updates.

Basic Qualifications

• Master’s degree with minimum 6 years of Pharmaceutical/Biotechnology experience in Quality, Operations, Scientific, or Manufacturing fields

Must-Have Skills

• Strong understanding of GMP requirements, US FDA, and ICH regulations
• Proven technical expertise in Chromatographic techniques /software and overlays
• Expertise in GMP systems (Veeva, Empower, LIMS, Spotfire)
• Strong data management, analytical, and problem-solving skills
• Experience supporting cross-functional teams in matrixed, global environments
• Proficiency in MS Office (Word, Excel, PowerPoint, Teams)
• Excellent written and verbal communication across all levels of the organization
• Continuous improvement mindset with experience applying lean practices

Good-to-Have Skills

• Knowledge of stability data management and annual product review
• Experience in assembling annual product reviews
• Experience in business process improvement and electronic data tool development

Soft Skills

• Strong initiative and self-motivation
• Team-oriented mindset with focus on achieving shared goals
• Ability to work effectively in diverse, global, virtual environments with minimal supervision

What Success Looks Like

• Timely and accurate delivery of technical and regulatory reports
• Effective collaboration across global teams to meet project milestones
• Proactive improvements to data management processes and quality systems
• Contribution to team knowledge through peer training and mentorship

Growth & Development

This role offers opportunities to build advanced expertise in GMP compliance, regulatory authorship, and quality systems.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer. We will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We are committed to providing reasonable accommodation for individuals with disabilities during the application and interview process, in performing essential job functions, and in accessing employment benefits. Please contact us to request accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen