Senior Associate QA, International Affiliates

What you do

The Sr. Associate QA position will implement internal collaboration with Amgens global quality teams, manufacturing sites, commercial supply chains, Amgen affiliates, warehouses, and external logistic partners in various regions and countries. The role will support right-first-time quality systems activities, a resilient supply network, leverage compliance knowledge, and support continuous improvement initiatives. This role will also be a critical link between cross-functional teams to uphold the integrity and reliability of our quality standards

Roles and Responsibilities:

• Primarily Perform the QA Contact role on the Product complaint and Distribution Complaint records and support other QMTS records such as Quality Events, Change Control records, Clinical and Commercial Temperature Excursion records, Corrective and Preventive Actions, effectiveness verification, and documentation.
• Manage quality records, including those for complaints, product recalls, and returned goods, ensuring they meet regulatory and organizational standards.
• Support audits, including self-inspections and external vendor audits, ensuring compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP).
• Demonstrate knowledge of key regulatory guidelines, including c GDP and cGMP for pharmaceutical/ device products.
• Understand and incorporate risk management strategy into the overall supply chain strategy
• Ensure accurate, complete, and timely documentation of quality records, including deviations, CAPA, change controls, and audit findings.
• Develop quality reports and metrics to track key performance indicators (KPIs) related to quality assurance and compliance.
• Identify and lead initiatives for process improvement, driving quality and operational efficiency through structured methodologies.
• Collaborate with cross-functional teams to implement best practices in quality assurance processes, ensuring continuous improvement.
• Participate in training sessions for quality and compliance, promoting an organizational culture of quality excellence
• Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.

What we expect from you

Education and Experiences:

• 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:
• Bachelors degree in science or engineering and 2+ years of professional experience in related fields.
• Understanding of GMP/GDP requirements.
• Familiarity with logistics processes of parcel, transport, and warehousing providers.
• Experience in final release and QMTS processes in global markets
• Strong technical writing skills.

Preferred Qualifications:

• Strong continuous improvement mindset 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, and 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 prioritize