Manager IDQ Affiliates & Global Distribution Quality

Amgen; Hyderabad; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Amgen is seeking a Manager of Quality Assurance to lead a team of quality professionals and uphold high standards across global sites. You will ensure right-first-time quality systems, manage documentation, and drive continuous improvement in line with cGMP, GDP, and regulatory expectations.

This role emphasizes cross‑functional collaboration with manufacturing, supply chains, and regulatory affairs to support inspections and timely quality decisions that protect patient safety and product

Qualifications

• Bachelor’s degree in quality management or related field with 8–13 years of experience.
• Minimum 2 years in a cGMP manufacturing environment with regulatory understanding.
• Ability to influence and inspire others.

Responsibilities

• Oversee a group of 5 to 10 staff and manage activities in a compliant, structured manner.
• Develop, implement, and maintain quality records in line with industry standards and regulatory requirements.
• Lead internal audits and coordinate external audits to ensure quality compliance.
• Prepare, review, and approve GMP/GDP documentation and quality agreements.
• Provide support for regulatory inspections in domestic and foreign sites.
• Collaborate cross-functionally to ensure seamless task transitions and continuity.

Skills

Quality assurance leadership

cGMP experience

Regulatory collaboration

Education

Bachelor’s degree in a related field

Job description

Overview

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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.

Role Description

In this role, you will serve patients through internal collaboration with Amgen’s global quality teams, manufacturing sites, commercial supply chains, Amgen affiliates, warehouses, and external logistic partners in various regions and countries. You will contribute to ensuring high‑quality and right‑first‑time quality systems activities at Amgen, build and support a resilient supply network, and conclude with a positive patient experience. The Manager of Quality Assurance will support the implementation and management of quality assurance activities at the Amgen Technology and Innovation Center, and will be responsible for leading a team of quality professionals who will maintain and approve various quality documents, including but not limited to quality documentation and metrics, validation documentation, investigations, CAPA and audit records, and quality agreements. This role will involve collaboration with various Amgen teams to ensure seamless handoffs between teams.

Roles & Responsibilities

• Oversee a group of 5 to 10 staff, ensuring their activities and priorities are managed in a compliant, structured manner.
• Ensure team members are appropriately qualified and trained to perform quality activities per company procedures.
• Conduct goal setting, performance reviews, and compensation planning.
• Develop, implement, and maintain the quality records in compliance with industry standards and regulatory requirements.
• Continuously improve documentation processes to enhance efficiency and quality by applying lean principles and automation.
• Conduct internal audits and coordinate external audits to ensure quality compliance.
• Analyze data and metrics to identify trends and areas for improvement within the quality systems.
• Work cross‑functionally and cross‑regionally with various Amgen teams and stakeholders to ensure seamless task transitions and continuity across groups.
• Prepare, review, and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.
• Provide support for domestic and foreign regulatory agency site inspections.
• What we expect of you: We are all different, and we value unique contributions. The professional we seek is an individual who brings these qualifications and attributes to the role.

Basic Qualifications and Experience

• Bachelor’s degree with 8 to 13 years of experience in quality management systems or a related field.

Must‑Have Skills

• Working foundation in quality assurance roles and proven team leader.
• Minimum of 2 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
• Ability to have a positive impact on others; the ability to influence behaviors of others by connecting with and inspiring them.

Good‑to‑Have Skills

• Experience in investigations, project management, trending and analysis.
• Relevant experience in supplier management, raw materials, packaging components, and/or device manufacturing.
• Understanding of the applicable manufacturing/testing processes (e.g., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).
• Proven experience in designing and/or improving processes at conceptual level.
• Desire to partner with internal and external stakeholders across teams.
• Understanding of industry requirements/expectations of a robust Quality Management System and documentation.
• Solid background on digital ecosystem.

Soft Skills

• Excellent analytical and troubleshooting skills.
• Strong verbal and written communication skills.
• Ability to work effectively with global, virtual teams.
• High degree of initiative and self‑motivation.
• Ability to manage multiple priorities successfully.
• Team‑oriented, with a focus on achieving team goals.
• Strong presentation and public speaking skills.

Benefits

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Equal Employment Opportunity Statement

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.