Sr Assoc QA - Global Supply Quality

Overview

Sr Associate QA (Global Supply Quality) provides quality oversight for alliance partnerships and external supply portfolio management within Amgen’s Global Supply Quality team.

What you'll do

• Serve as the QA contact for partners to ensure adherence to quality agreements and identify performance improvement opportunities.
• Perform partner/client assessments for change control and deviation records.
• Execute partnership alliance quality tasks including document revisions/redactions and supporting partner audits.
• Support due diligence activities related to portfolio strategy execution.
• Work with stakeholders to ensure compliance with GMP/GDP.
• Prepare, review, and approve SOPs and other GMP/GDP documentation aligned with corporate and regulatory requirements.
• Support internal/external audits and inspections and contribute to operational improvement initiatives.

What you'll need

• Bachelor’s degree in science or engineering.
• 2+ years of professional experience in related fields.
• Understanding 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.

Details

• Location: Hyderabad, India.