Sr Assoc QA - Global Supply Quality

Amgen; India; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amgen seeks a Sr. Associate QA to provide quality oversight of alliance partnerships and external supply portfolio management.

The role integrates with cross-functional teams including Contract & Development Manufacturing, Process Development, and Supply Chain to uphold quality agreements and regulatory standards. Responsibilities include QA roles for partner assessments, change control, deviation handling, and ensuring adherence to cGMP/cGDP.

Qualifications

• Bachelor's degree in science or engineering with 2+ years of related experience.
• Understanding of GMP/GDP requirements.
• Familiarity with raw material compendial testing.
• Experience overseeing quality of suppliers or external parties.
• Strong technical writing skills.
• Experience in Alliance Management.

Responsibilities

• Quality oversight of Amgen's alliance partnerships and external supply portfolio management.
• QA contact role for partners to ensure adherence to quality agreements and identify improvements.
• Assess Change Control and Deviation records for partners/clients.
• Support QA tasks for Portfolio Strategy Execution and due diligence activities.
• Collaborate with stakeholders to ensure GMP/GDP compliance across end-to-end processes.
• Prepare, review and approve SOPs and other GMP/GDP documentation.

Skills

Technical writing

Alliance management

Project management

Analytical skills

Communication

Multitasking

Education

Bachelor's degree in science or engineering

Tools

Microsoft Office

Job description

Career Category
Quality
Job Description
Description

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab , to manufacturing plant , to patient . Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.

We are seeking a highly motivated individual for our Global Supply Quality ( GSQ ) team. This is an incredibly exciting opportunity to join a team of quality professionals .

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 meaningful role.

Live

What you will do

The Sr. Associate QA position is responsible for the Quality oversight of Amgen's alliance partnerships and external supply portfolio management. This position is responsible for being an integral quality member of the Amgen cross-functional External Supply and Business Development teams that includes but is not limited to Amgen Contract & Development Manufacturing, Process Development, Supply Chain, and Business Development .

Responsibilities :

• Working independently, the individual will be responsible for , but not limited to the following:
• Perform QA Contact role for partners to ensure adherence to quality agreements , identifying performance improvement opportunities
• Perform Partner/Client assessments for Change Control and Deviation records
• Perform Quality tasks in support of Partnership Alliance Quality in accordance with Quality Agreements ( i.e. document revisions, document redactions, support partner audits)
• May p erform QA responsibilities associated with Portfolio Strategy Execution, such as supporting Due Diligence activities
• Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP /GDP .
• 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) and other applicable regulations
• Collaborate with external suppliers and partners
• Understand and incorporate risk management strategy into the overall external supply lifecycle
• Support in tactical activities related to internal/external audits and inspections
• Tak e part in operational improvement initiatives, programs, and projects
• Develop solutions that are thorough, practical, and consistent with functional objectives
• Ownership of business metrics, performance assessments, and other key documents to inform the health of external supplier and partner relationships.
• Work under minimal supervision in line with Amgen Values and Leadership Attributes.

Win

What we expect of you :

Education and Experiences:

• Bachelor's degree in science or engineering and 2 + years of professional experience in related fields.
• U nderstanding of GMP/GDP requirements.
• Familiarity with raw material compendial testing
• Experience overseeing quality of suppliers or external parties
• Strong technical writing skills.
• Strong experience in Alliance Management

Preferred Qualifications

• Strong continuous improvement mindset and lean practices experience.
• U nderstanding 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.
• Ability to multi-task and prioritiz e