Senior Manager Manufacturing Programs - Investigations and Process Ownership

Career Category

Job Description

How Might You Defy Imagination? 

At Amgen, our shared mission—to serve patients—drives all that we do. Amgen North Carolina (ANC) is home to our newest and most advanced drug substance manufacturing plant, designed with flexibility, embedded industry 4.0 capabilities, and sustainability innovations as we progress toward Amgen’s goal of carbon neutrality by 2027. 

We are seeking a Senior Manager of Manufacturing Programs to lead both the Major Deviation Investigation Team and the Process Ownership function at ANC. This leadership role has high site visibility and is pivotal in ensuring that deviations are investigated with rigor, accuracy, and compliance, while manufacturing processes remain in a state of control through effective ownership of SOPs, CAPAs, and Change Controls. 

Senior Manager Manufacturing Programs - Investigations and Process Ownership

What You Will Do 

As Senior Manager, you will provide leadership and operational oversight for both the Investigations and Process Ownership functions at ANC.

Investigation Leadership 

• Provide leadership and oversight of the Major Deviation Investigation Team, ensuring effective management of investigation timelines, technical writing, and CAPA development. 

• Lead the Major Investigation Writing Team responsible for high-complexity deviation investigations within ANC’s Drug Substance Flex Batch Manufacturing operations. 

• Provide direct management, coaching, and development to investigators, fostering strong technical writing, problem-solving, and critical thinking skills. 

• Ensure investigation quality and consistency, overseeing documentation for accuracy, compliance, and readiness for regulatory inspection. 

• Establish best practices, standardized processes, and metrics to continuously improve the deviation investigation system. 

• Serve as the point of contact for escalation of critical investigations and communicate investigation outcomes to site and global leadership. 

• Present investigations and findings to regulatory inspectors, internal auditors, and senior leadership. 

Process Ownership Leadership 

• Provide leadership and oversight to the Process Ownership organization, including a Manager of Process Owners and their team. 

• Ensure effective lifecycle management of manufacturing processes and associated documentation, including Standard Operating Procedures (SOPs), aligned with current operations and batch records. 

• Oversee Manufacturing CAPAs and Change Controls, ensuring timely progression, high-quality execution, and compliance with site and global standards. 

• Ensure alignment between investigation outcomes and process ownership activities to support effective implementation of corrective and preventative actions. 

• Promote effective use of project management tools and structured problem-solving approaches to support execution and visibility to timelines. 

• Support development of technical capability within the team through coaching, mentoring, and knowledge sharing. 

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Cross-Functional & Strategic Leadership 

• Partner cross-functionally with Manufacturing, Quality, Engineering, Process Development, Analytical Sciences, Supply Chain, and Regulatory Affairs. 

• Influence site-level decision-making on deviation management strategies, process improvements, and CAPA execution. 

• Driv