Senior Manager Quality Assurance – Incoming Quality Raw Materials /Disposition

Role Summary

Lead a team of Quality professionals supporting the Disposition and Incoming Quality operations at our North Carolina site. Provide technical quality leadership and oversight of Disposition and Incoming Quality, partnering closely with cross-functional teams to build, enhance and sustain compliant commercial operations. Drive development and continuous improvement of the site's inspection readiness program and overall Quality Management System (QMS), ensuring compliance with Amgen standards, cGMP, and applicable regulations.

Responsibilities

• Lead, manage, and motivate a high-performing team of Quality professionals across key areas, including QA support for Disposition and Incoming QA, and their applicable quality systems (e.g., Document Management, Change Control, and Deviations).
• Ensure team members are properly trained and qualified to perform their duties in accordance with cGMP and regulatory requirements.
• Oversee workload distribution, resource planning, and departmental budgeting, including forecasting and monitoring.
• Own the development, implementation, and continuous improvement of the site's inspection readiness program and overall Quality Management System (QMS), ensuring compliance with Amgen standards, cGMP, and applicable regulations.
• Ensure timely review, approval, and tracking of key cGMP processes, documents, and records, including deviations, CAPAs, Change Controls, validation protocols, and assays.
• Lead cross-functional investigations of deviations, ensure appropriate documentation, and assess changes for potential product quality impact.
• Stay current with regulatory developments and quality trends to maintain a compliant and forward-thinking quality program.
• Represent the Quality unit during internal and external audits and regulatory inspections.
• Alert senior management to significant quality, compliance, supply, or safety risks, using sound judgment and cross-functional coordination when needed.
• Manage hiring, succession planning, and performance development to ensure organizational capability and talent pipeline.

Qualifications

• Required: High school diploma / GED and 12 years of Quality and Manufacturing support industry experience OR
• Required: Associate’s degree and 10 years of Quality and Manufacturing support industry experience OR
• Required: Bachelor’s degree and 8 years of Quality and Manufacturing support industry experience OR
• Required: Master’s degree and 6 years of Quality and Manufacturing support industry experience OR
• Required: Doctorate degree and 2 years of Quality and Manufacturing support industry experience

• Preferred: Educational background in Life Science and/or Engineering
• Preferred: Proven experience in Quality oversight of Incoming, Warehouse, and Disposition, with a strong focus on quality systems.
• Preferred: In-depth knowledge of cGMPs, regulatory requirements, and pharmaceutical processing, with demonstrated ability to apply compliance principles in practice.
• Preferred: Hands-on experience with Disposition, Incoming, and Quality Systems—particularly investigations, corrective actions, and audit readiness.
• Preferred: Experience managing and interacting with regulatory and internal auditors.
• Preferred: Demonstrated leadership of Quality teams, with strong team development, collaboration, and mentoring skills.
• Preferred: Effective risk management, negotiation, and cross-functional collaboration abilities.
• Preferred: Excellent written and verbal communication, facilitation, and presentation skills in both English and Spanish.

Education

• Educational background in Life Science and/or Engineering
• Additional certifications in quality systems or regulatory affairs are a plus