Senior Associate QA, International Distribution Quality

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

Job summary

Amgen Inc. (IR) in Hyderabad is seeking a Senior Associate QA for the International Distribution Quality team. You will oversee global product distribution quality and provide QA oversight of Supply Chain operations.

The role involves leading QA activities for distribution, audits, SOPs, and regulatory compliance, working across functions and with third parties. A science/engineering degree and 7+ years' experience are required, with GMP/GDP expertise.

Qualifications

• Bachelor’s degree in science or engineering and 7+ years of experience in quality or supply chain.
• Understanding of GMP/GDP requirements.
• Familiarity with parcel, transport, and warehousing logistics.
• Experience in Validation/Qualification of processes, equipment, and facilities.
• Strong technical writing skills.

Responsibilities

• Perform QA contact role on Quality Events, Change Controls, CAPA, and distribution complaints.
• Collaborate with cross-functional partners to ensure GMP/GDP compliance.
• Assess quality impacts of distribution deviations and transport temperature excursions.
• Lead internal audits or self-inspections and support supplier audits.
• Own supplier metrics and performance assessments to monitor relationships.

Skills

GMP/GDP knowledge

Technical writing

Logistics knowledge

Education

Bachelor’s degree in science or engineering

Tools

Power BI

SharePoint

Excel

Word

PowerPoint

Job description

Senior Associate QA, International Distribution Quality

What you will do

We are seeking a highly motivated individual for our International Distribution Quality (IDQ) team. This is an incredibly exciting opportunity to join a team of quality professionals in global distribution team.

Role Description

The Sr. Associate QA position will implement and oversee global product distribution and transportation from Amgen’s Global Supply Hubs to Amgen’s global markets and provide QA oversight of QA activities for Global Supply Chain operations.

This role may require working in shifts or extended hours within the same shift. Working independently, the individual will be responsible for, but not limited to the following:

• Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation, as well as QA triage of Distribution complaints.
• Work closely with all relevant collaborators for the end-to-end process and ensure compliance to GMP/GDP.
• Expertise in quality assessment associated with transport temperature excursion management.
• Expertise in assessing quality impacts of distribution deviations.
• Hands‑on experience in internal audits or self‑inspections.
• Demonstrated experience in batch disposition and release processes.
• Act as subject matter expert (SME) for transportation related Quality Processes.
• 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.
• Collaborate with the 3rd Parties to ensure adherence to service levels, identifying and implementing performance improvement.
• Understand and incorporate risk management strategy into overall supply chain strategy.
• Provide support for logistic service provider and transportation service provider oversight.
• Support in tactical activities for internal/external audits and inspections as part of the audit/inspection team.
• Provide quality expertise and guidance to operational staff and within cross functional Amgen teams.
• Take part in operational improvement initiatives, programs, and projects.
• Develop solutions that are thorough, practical, and consistent with functional objectives.
• Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships.
• Work under minimal supervision in line with Amgen Values and Leadership Attributes.

Basic Qualifications

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications:

• Bachelor’s degree in science or engineering and 7+ years of professional experience in related fields.
• Understanding of GMP/GDP requirements.
• Familiarity with logistics processes of parcel, transport, and warehousing providers.
• Experience in Validation/Qualification of processes, equipment, and facilities.
• Strong technical writing skills.

Preferred Qualifications

• Global Supply Quality Background.
• Distribution Quality background.
• Strong continuous improvement attitude and lean practices experience.
• Understanding of end-to-end supply chain business processes.
• Experience in project management across multiple departments and geographies.
• Quick process understanding, insight and visualizing.
• Strong analytical and problem‑solving skills.
• Independent self‑starter, able to work autonomously, under pressure and in teams.
• GMP/GDP knowledge and understanding of pharmaceutical regulations.
• Energetic, detail oriented, highly motivated with a “can do” outlook.
• Change management skills.
• Ability to communicate across all levels of the organization.
• Effective written and verbal communication skills.
• Experience with Microsoft Office Tools including Excel, Word, and PowerPoint, Power BI and SharePoint.
• Ability to multi-task and prioritize.

What you can expect of us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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

Company Information

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Equal Opportunity Employer

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.