Senior Associate QA, Global Supply Quality (GSQ)

What you will do

The Sr. Associate QA position is responsible for the Quality and Compliance Oversight of Raw material suppliers. This position is responsible for being an integral quality member of the Amgen cross-functional raw materials suppliers team that includes but is not limited to business operations, analytical science, process development, and supply chain.

Role Description

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.
• Provide support to the supplier periodic monitoring oversight activities.
• Provide support for supplier audits (planning, documentation, follow-up actions) and track completion of commitments in accordance with Amgen procedure/policy.
• Ensure change notifications are assessed for risk, documentation is complete, and approvals align with the Quality Management System.
• 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), Good Distribution Practices (GDP) and other applicable regulations
• Collaborate with raw material suppliers to ensure adherence to quality agreements, identifying performance improvement opportunities
• Understand and incorporate risk management strategy into the overall raw material lifecycle
• Support in tactical activities related to internal/external audits and inspections
• Perform routine quality assessments and provide approval of changes to raw material inspection profiles
• 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.
• This role may require working in shifts or extended hours within the same shift to support global timezones.

What we expect of 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:

• Masters/Bachelors degree with 5 to 9 years of experience in quality management systems or a related field

Functional Skills

• Experience and strong familiarity with digital tools and computerized systems.
• 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, 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