Senior Manager Quality Control

Job Summary

This role will be responsible for managing and developing team strategies for the Global Quality Control network function, ensuring team deliverables are met per Service Level Agreement (SLA) requirements for Quality Control Information Systems. Provides clarity for the team's vision and strategy and ensures that efforts are prioritized to support them.

Key Responsibilities:

• Develop team strategy for Global QC network support function ensuring team deliverables are met per SLA requirements.
• Provides clarity for the team's vision and strategy and ensures that efforts are prioritized to support them.
• Position requires strong project management skills, ensuring deliverables are on target, roadblocks are quickly resolved, and network alignment is maintained.
• Partner with global site leads and network leads to shape global strategy of QC systems
• Manage staff and develop best team. Maximize team capacity in meeting deliverables by removing roadblocks and driving cross functional and cross site alignment initiatives.
• Requires ownership and deep understanding of Lean guiding principles to proactively drive continuous improvement initiatives to fruition.
• Maintain scheduling, control boards, issue tracking, and drive resolution.
• Provide metrics and monthly reports for management review and other forums; drive improvements based on metrics control plan with meaningful action plans.
• This individual will play a primary role in partner and regulatory audits (FDA, EMEA, etc.), including face to face interaction.
• Ensure safety of staff though engaged safety inspections, SEE card submission reviews, and timely INCAs investigation closures.
• Ownership and approval of SOPs and other documents in QC, as required

Basic Qualifications:

Doctorate degree and 2 years of Quality Control or Quality Assurance experience
OR
Master's degree and 4 years of Quality Control or Quality Assurance experience
OR
Bachelor's degree and 6 years of Quality Control or Quality Assurance experience
OR
Associate's degree and 10 years of Quality Control or Quality Assurance experience
OR
High school diploma / GED and 12 years of Quality Control or Quality Assurance experience

Preferred Qualifications:

• Develop team strategy for Global QC network support function ensuring team deliverables are met per SLA requirements.
• Provides clarity for the team's vision and strategy, and ensures that efforts are prioritized to support them.
• Position requires strong project management skills, ensuring deliverables are on target, roadblocks are quickly resolved and network alignment is maintained.
• Partner with global site leads and network leads to shape global strategy of QC systems
• Manage staff and develop best team. Maximize team capacity in meeting deliverables by removing roadblocks and driving cross functional and cross site alignment initiatives.
• Requires ownership and deep understanding of Lean guiding principles to proactively drive continuous improvement initiatives to fruition.
• Maintain scheduling, control boards, issue tracking, and drive resolution.
• Provide metrics and monthly reports for management review and other forums; drive improvements based on metrics control plan with meaningful action plans.
• This individual will play a primary role in partner and regulatory audits (FDA, EMEA, etc.), including face to face interaction.
• Ensure safety of staff though engaged safety inspections, SEE card submission reviews, and timely INCAs investigation closures.
• Ownership of Major Deviations, as required
• Ownership and approval of SOPs and other documents in QC, as required

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.