Senior Manager Manufacturing Programs - Investigations and Process Ownership

Amgen•Holly Springs, NC

About The Position

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. 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. Drive initiatives to enhance efficiency, knowledge sharing, and compliance across investigation and process ownership functions. Support regulatory inspections and audits by ensuring both investigation and process ownership systems are inspection-ready. What We Expect of You

Requirements

High school diploma / GED and 12 years of Quality or Operations experience OR Associates degree and 10 years of Quality or Operations experience OR Bachelor’s degree and 8 years of Quality or Operations experience OR Master’s degree and 6 years of Quality or Operations experience OR Doctorate degree and 2 years of Quality or Operations experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
Your managerial experience may run concurrently with the required technical experience referenced above

Nice To Haves

8+ years related work experience in biotech or pharmaceutical industry
Prior people leadership experience
Strong background in compliance, root cause analysis, and CAPA/change management
Experience with Quality Management Systems (e.g., Veeva, TrackWise)
Proven track record with regulatory inspections and audits
Excellent organizational and communication skills
Strong interpersonal and cross-functional collaboration skills

Responsibilities

Provide leadership and operational oversight for both the Investigations and Process Ownership functions at ANC.
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.
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.
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.
Drive initiatives to enhance efficiency, knowledge sharing, and compliance across investigation and process ownership functions.
Support regulatory inspections and audits by ensuring both investigation and process ownership systems are inspection-ready.