Senior Associate QA, International Distribution Quality

MedDeviceJobs; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Amgen is seeking a Senior Associate QA for International Distribution Quality in Hyderabad. The role focuses on global product distribution QA, GMP/GDP compliance, and collaboration with cross-functional teams to ensure end-to-end quality across the supply chain.

You will oversee QA activities, drive process improvements, and provide guidance to operational staff while supporting audits and regulatory requirements.

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.

Responsibilities

• Perform QA Contact role on Quality Events, Change Control, CAPA, effectiveness verification, and distribution complaints.
• Work with collaborators for end-to-end process and ensure GMP/GDP compliance.
• Expertise in 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 SME for transportation related Quality Processes.
• Prepare, review and approve SOPs and other GMP/GDP documentation to ensure regulatory alignment.
• Collaborate with 3rd Parties to ensure service levels and performance improvement.
• Understand and incorporate risk management into overall supply chain strategy.
• Provide support for logistic service provider oversight.
• Support audits and inspections as part of audit/inspection team.
• Provide quality guidance to operational staff and cross functional teams.
• Take part in operational improvement programs and projects.
• Develop solutions aligned with functional objectives.
• Own supplier metrics and health of supplier relationships.
• Work under minimal supervision consistent with Amgen values.

Skills

Strong leadership

Analytical skills

Problem-solving

Independent and autonomous

Cross-functional collaboration

Lean and continuous improvement

Education

Bachelor’s degree in science or engineering

Tools

Power BI

SharePoint

Excel

Word

PowerPoint

Job description

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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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.

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this relevant role.

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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. 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.

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.

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.

GCF Level

GCF Level 04

Career Category

Quality

Position Type

Full time