Quality Assurance Senior Manager

• Ensure appropriate quality oversight of suppliers in line with global regulations, defines quality requirements for suppliers and monitors performance
• Monitors and assigns quality status and, if required, determines remediation actions and additional oversight needed, including technical site visits
• Maintains key quality performance indicators for suppliers of responsibility
• Review and approval of quality records such as
• Quality Agreements, supplier investigations, deviations, supplier change notifications, change controls, CAPAs, and CAPA-EV's
• Manage supplier audits to completion
• Act as point of contact for Amgen sites to resolve concerns and support projects regarding secondary packaging materials and suppliers
• Represent Amgen at product-specific regulatory inspections and/or during Notified Body audits of supplier site
• Identify and mitigate risks at supplier site and raise to management as appropriate
• Onboard and offboard suppliers and/or manufacturing location as needed
• Lead departmental improvement projects regarding continuous improvement and automation

• Doctorate degree and 2 years of Quality and Compliance experience
• Master's degree and 4 years of Quality and Compliance experience
• Bachelor's degree and 6 years of Quality and Compliance experience
• Associate's degree and 10 years of Quality and Compliance experience
• High school diploma / GED and 12 years of Quality and Compliance experience
• Educational background in Life Sciences
• Strong technical knowledge and experience within operations in the pharmaceutical or GMP-regulated industry
• Relevant work experience within Drug Product and Finished Drug Product operations
• 5+ years of experience overseeing quality of suppliers
• Robust problem-solving and root-cause analysis experience
• Strong continuous improvement mentality
• Strong compliance, quality, and regulatory knowledge with critical thinking, inquisitive with an end-to-end mentality
• Strong communication skills with proficiency in the English language and collaborative cross-functionally behavior
• Strong report writing and presentation skills
• Experience driving decision-making by using DAI principles
• Understanding of industry requirements/expectations of a QMS
• Savvy with data and Artificial Intelligence tools
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

Knowledge of Primary and Secondary packaging is a plus

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible