Manager IDQ Affiliates & Global Distribution Quality

Amgen Technology; Hyderabad; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Amgen in Hyderabad, India is seeking a Manager of Quality Assurance to lead a 5–10 person team across global quality systems, ensuring compliance with cGMP, GDP, and regulatory requirements. The role includes maintaining quality records, investigations, CAPA, and audits, and supporting site inspections.

You will collaborate with manufacturing, quality, and regulatory teams to drive process improvements using lean principles and automation while overseeing training and performance reviews to

Qualifications

• Bachelor's degree with 8–13 years in quality management systems.
• Experience in cGMP manufacturing and regulatory standards.
• Proven ability to lead and develop quality teams.

Responsibilities

• Oversee a group of 5–10 staff in a compliant, structured manner.
• Ensure team qualification and training per procedures.
• Conduct goal setting, performance reviews, and compensation planning.
• Develop and maintain quality records per regulatory standards.
• Lead audits and coordinate external inspections.
• Analyze data to identify trends in quality systems.

Skills

Quality leadership

Team leadership

Quality assurance

cGMP knowledge

Education

Bachelor's degree

Job description

Job Summary

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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 lay within them, youll 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 worlds toughest diseases and make peoples 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 whats known today.

Role Description

In this role, you will serve patients through internal collaboration with Amgens 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, as well as 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.

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.

Basic Qualifications and Experience

• Bachelors 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 affect the behaviors of others by connecting with and inspiring them

Good-to-Have Skills

• Experience in investigations, project management and trending and analysis
• Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.
• Understanding of the applicable manufacturing/testing processes (i.e. 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 eco system.

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.