Quality Assurance Senior Manager

What you will do

This QA Sr. Manager role will be responsible for the quality oversight of primary component suppliers. This person is an integral member of the Amgen cross-functional supplier team(s) that includes, but is not limited to, business operations, process development, supply chain and combination product quality.

Key Responsibilities

• Act as the quality lead for supplier relationships, from onboarding through disengagement, ensuring performance through robust proactive monitoring, technical site visits, and continuous improvement.
• Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards, including but not limited to GDP, GMP, ISO, etc and Amgen’s industry leading expectations.
• Negotiator and owner of quality agreements
• Prepare external sites for inspections including development of inspection playbooks.
• Represent Amgen at external supplier site during product-specific Regulatory Inspections and/or during notified body audits of supplier, as applicable or required
• Present on topics during inspections demonstrating appropriate behaviors and knowledge of the subject areas
• Review/Approve supplier investigations, events and change notifications
• Quality approver of deviations, change controls, CAPA, CAPA EVs
• Identify and mitigate risk at the supplier and/or escalate to management
• Perform Person in Plant activities, as deemed appropriate
• Drive audit commitments to completion
• Lead supplier audit preparation and identify areas of focus
• Continuously assess supplier status through periodic monitoring reporting
• Partner with Operations site lead on issues, improvements, site performance and overall relationship management
• Understand and implement GMP requirements internally and externally

Up to 20% of domestic and international travel required. This role may work on-site at one of the following locations: Thousand Oaks, CA, Cambridge, MA, Greenwich, RI, Tampa, FL, or Puerto Rico. Open to remote associates in any US location.

Basic Qualifications

• Doctorate degree and 2 years of Quality experience OR
• Master’s degree and 4 years of Quality experience OR
• Bachelor’s degree and 6 years of Quality experience OR
• Associate’s degree and 10 years of Quality experience OR
• High school diploma / GED and 12 years of Quality experience

Preferred Qualifications

• 10+ years biotech or pharmaceutical industry experience
• 5+ years of experience overseeing quality of suppliers
• Experience with leading audits
• Technical knowledge related to primary components
• Experience with Quality Processes and systems such as Trackwise and Veeva
• Experience with quality oversight of primary components
• History of presenting during inspections and audits
• Able to facilitate and influence senior stakeholders and partners
• Able to successfully prioritize workload and meet timelines
• Ability to negotiate a strategic position after receiving feedback from multiple sources
• Strong project management, problem-solving, and analytical skills
• Demonstrated ability to lead cross-functional teams, consistently deliver timely, and high-quality results
• Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Experience with relationship management with external parties
• Savvy with data and Artificial Intelligence tools